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Thunder Dome 2027: Vote Now to Help Support AFSOC's Newest Innovations
HURLBURT FIELD, Florida, Oct. 22 -- The U.S. Air Force Special Operations Command issued the following news:
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Thunder Dome 2027: Vote now to help support AFSOC's newest innovations
Oct. 21, 2026
HURLBURT FIELD, Fla. -- Air Force Special Operations Command will host its fourth annual Thunder Dome Innovation Competition in fiscal year 2027. The program allows Air Commandos to pitch tactical concepts directly to senior leadership for development funding and prototype support.
Thunder Dome focuses on rapidly developing these concepts into usable tools for frontline units. The program receives ... Show Full Article HURLBURT FIELD, Florida, Oct. 22 -- The U.S. Air Force Special Operations Command issued the following news: * * * Thunder Dome 2027: Vote now to help support AFSOC's newest innovations Oct. 21, 2026 HURLBURT FIELD, Fla. -- Air Force Special Operations Command will host its fourth annual Thunder Dome Innovation Competition in fiscal year 2027. The program allows Air Commandos to pitch tactical concepts directly to senior leadership for development funding and prototype support. Thunder Dome focuses on rapidly developing these concepts into usable tools for frontline units. The program receivesproposals from Airmen across active duty, Air National Guard, and Air Force Reserve components across the command. Winning teams receive direct innovation funding and program office advocacy to prototype, test, and field their solutions.
Voting for the next Thunder Dome Innovation Competition is now open and runs through Oct. 26, 2026. Select the best game-changing ideas to solve our toughest challenges, your vote will help determine the finalists.
Use this link to set up your Department of War-registered account and cast your three votes for the most impactful ideas. Every Air Commando voice matters!
Ahead of the next Thunder Dome competition, several winning projects from last year's program are already yielding dividends across multiple operational disciplines:
Project SilentSentinel -- 193rd Special Operations Wing, Harrisburg International Airport, Pennsylvania ($51,000 awarded):
The 193rd SOW team leveraged additive manufacturing and rapid prototyping to produce 27 custom-shielded lock boxes. The units are currently prepared for tactical field evaluation and stress-testing during upcoming training exercises to validate physical security and RF-shielding capabilities.
Project IRIS -- 137th Special Operations Wing, Will Rogers Air National Guard Base, Oklahoma ($51,000 awarded):
Air Commandos assigned to the 137th SOW procured specialized communications tracking tags and optical radio frequency scanners. Following initial operational validation within the communications flight, the Wing is developing integration pathways to expand tracking architecture into its security forces, logistics readiness, and force support services squadrons.
Explosive Ordnance Disposal Range Modernization -- 1st Special Operations Wing, Hurlburt Field, Florida ($510,000 awarded):
The 1st SOW team worked to overhaul tactical demolition and munitions disposal training infrastructure. The modernization project is nearing completion and will support multi-hazard training environments for EOD proficiency.
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Original text here: https://www.afsoc.af.mil/News/Article-Display/Article/4630827/thunder-dome-2027-vote-now-to-help-support-afsocs-newest-innovations/
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Thunder Dome 2027: Vote now to help support AFSOC's newest innovations
Oct. 21, 2026
HURLBURT FIELD, Fla. -- Air Force Special Operations Command will host its fourth annual Thunder Dome Innovation Competition in fiscal year 2027. The program allows Air Commandos to pitch tactical concepts directly to senior leadership for development funding and prototype support.
Thunder Dome focuses on rapidly developing these concepts into usable tools for frontline units. The program receives ... Show Full Article HURLBURT FIELD, Florida, Oct. 22 -- The U.S. Air Force Special Operations Command issued the following news: * * * Thunder Dome 2027: Vote now to help support AFSOC's newest innovations Oct. 21, 2026 HURLBURT FIELD, Fla. -- Air Force Special Operations Command will host its fourth annual Thunder Dome Innovation Competition in fiscal year 2027. The program allows Air Commandos to pitch tactical concepts directly to senior leadership for development funding and prototype support. Thunder Dome focuses on rapidly developing these concepts into usable tools for frontline units. The program receivesproposals from Airmen across active duty, Air National Guard, and Air Force Reserve components across the command. Winning teams receive direct innovation funding and program office advocacy to prototype, test, and field their solutions.
Voting for the next Thunder Dome Innovation Competition is now open and runs through Oct. 26, 2026. Select the best game-changing ideas to solve our toughest challenges, your vote will help determine the finalists.
Use this link to set up your Department of War-registered account and cast your three votes for the most impactful ideas. Every Air Commando voice matters!
Ahead of the next Thunder Dome competition, several winning projects from last year's program are already yielding dividends across multiple operational disciplines:
Project SilentSentinel -- 193rd Special Operations Wing, Harrisburg International Airport, Pennsylvania ($51,000 awarded):
The 193rd SOW team leveraged additive manufacturing and rapid prototyping to produce 27 custom-shielded lock boxes. The units are currently prepared for tactical field evaluation and stress-testing during upcoming training exercises to validate physical security and RF-shielding capabilities.
Project IRIS -- 137th Special Operations Wing, Will Rogers Air National Guard Base, Oklahoma ($51,000 awarded):
Air Commandos assigned to the 137th SOW procured specialized communications tracking tags and optical radio frequency scanners. Following initial operational validation within the communications flight, the Wing is developing integration pathways to expand tracking architecture into its security forces, logistics readiness, and force support services squadrons.
Explosive Ordnance Disposal Range Modernization -- 1st Special Operations Wing, Hurlburt Field, Florida ($510,000 awarded):
The 1st SOW team worked to overhaul tactical demolition and munitions disposal training infrastructure. The modernization project is nearing completion and will support multi-hazard training environments for EOD proficiency.
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Original text here: https://www.afsoc.af.mil/News/Article-Display/Article/4630827/thunder-dome-2027-vote-now-to-help-support-afsocs-newest-innovations/
SRS Teams Honored With Defense Programs Award of Excellence
AIKEN, South Carolina, Oct. 22 -- The U.S. Department of Energy Savannah River Site issued the following news release:
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SRS teams honored with Defense Programs Award of Excellence
October 20, 2026
AIKEN, S.C. - During a ceremony held October 6, Dave Beck, Deputy Administrator for Defense Programs at the National Nuclear Security Administration (NNSA), recognized three Savannah River Site (SRS) project teams for their outstanding contributions to the nation's nuclear security. The teams received Defense Program Awards of Excellence from the NNSA Office of Defense Programs for work completed ... Show Full Article AIKEN, South Carolina, Oct. 22 -- The U.S. Department of Energy Savannah River Site issued the following news release: * * * SRS teams honored with Defense Programs Award of Excellence October 20, 2026 AIKEN, S.C. - During a ceremony held October 6, Dave Beck, Deputy Administrator for Defense Programs at the National Nuclear Security Administration (NNSA), recognized three Savannah River Site (SRS) project teams for their outstanding contributions to the nation's nuclear security. The teams received Defense Program Awards of Excellence from the NNSA Office of Defense Programs for work completedduring calendar year 2025 in support of maintaining the nation's nuclear weapons stockpile and its deterrence mission.
Beck commended the teams for their accomplishment, highlighting their sense of urgency in completing NNSA's mission critical work and the need to continue working with that sense of urgency in support of securing the nation's nuclear deterrent.
"Savannah River Site's work is increasingly vital to our nation's deterrence mission, and every member of this team is making a meaningful difference," said Beck. "You are part of an enterprise that is deterring our adversaries in a major way. We must deliver results with greater speed and urgency, and you are helping us do exactly that. Thank you for your commitment to this mission and for the important work you are doing to strengthen our nation's nuclear deterrent."
Established in 1982, the Defense Program Awards of Excellence are presented annually to honor significant individual and team achievements in quality, productivity, cost savings, safety and innovation supporting the nation's nuclear weapons and stockpile stewardship programs.
SRS teams recognized during the ceremony include:
Savannah River Tritium Enterprise (SRTE) Calendar Year (CY) 2025 Outage
SRTE completed the year-long CY25 Outage, replacing Cold War-era equipment critical to sustaining the nation's tritium supply, which is essential to the nation's nuclear deterrent. The team replaced chillers, compressors, hydride beds, and other major components, maneuvering large systems through restricted access points inside an operating nuclear facility. The outage delivered more than 560,000 work hours and modernized the H Area New Manufacturing facility, strengthening the nation's nuclear deterrent.
SRTE Tritium Extraction Facility (TEF) 2025-2026 Extractions
The SRTE TEF Team achieved a record-breaking production of 13 tritium extractions in just nine months across fiscal years 2025-2026. This accomplishment included extracting more than 3,000 TPBARs, processing six Legal Weight Truck cask shipments and two waste containers, and refurbishing 10 cutterheads--each essential to sustaining and advancing tritium extraction capabilities. Together, these efforts are critical to maintaining the readiness of the U.S. nuclear deterrent and ensuring the long-term availability of the nation's tritium supply.
High-Fidelity Training and Operations Center (HFTOC) Finalized Critical Decision (CD)-2/3 Package
The Savannah River Plutonium Processing Facility (SRPPF) project team finalized the HFTOC CD-2/3 package in less than nine months, advancing the plutonium pit production mission through design completion of the specialized prototyping and training facility. By rapidly incorporating review recommendations, the team completed the design ahead of schedule while accelerating a portion of CD 3X construction. Strategic glovebox conversions and supplier transitions reduced costs and improved long-term schedule performance for pit production, allowing for faster production in the future.
"These accomplishments demonstrate the exceptional expertise, teamwork and commitment of our SRS workforce. From modernizing critical infrastructure to advancing tritium extraction and supporting the nation's plutonium pit production mission, these teams are delivering with urgency and purpose. Their achievements are a testament to the vital role we play in strengthening national security and deterrence during an increasingly complex global environment," said SRNS President and CEO Jeff Griffin.
Following the ceremony, Beck toured key NNSA facilities and engaged in briefings with leaders from the NNSA Savannah River Field Office and Savannah River Nuclear Solutions (SRNS), the managing and operating contractor for SRS.
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Original text here: https://public.srs.gov/2026/10/srs-teams-honored-with-defense-programs-award-of-excellence/
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SRS teams honored with Defense Programs Award of Excellence
October 20, 2026
AIKEN, S.C. - During a ceremony held October 6, Dave Beck, Deputy Administrator for Defense Programs at the National Nuclear Security Administration (NNSA), recognized three Savannah River Site (SRS) project teams for their outstanding contributions to the nation's nuclear security. The teams received Defense Program Awards of Excellence from the NNSA Office of Defense Programs for work completed ... Show Full Article AIKEN, South Carolina, Oct. 22 -- The U.S. Department of Energy Savannah River Site issued the following news release: * * * SRS teams honored with Defense Programs Award of Excellence October 20, 2026 AIKEN, S.C. - During a ceremony held October 6, Dave Beck, Deputy Administrator for Defense Programs at the National Nuclear Security Administration (NNSA), recognized three Savannah River Site (SRS) project teams for their outstanding contributions to the nation's nuclear security. The teams received Defense Program Awards of Excellence from the NNSA Office of Defense Programs for work completedduring calendar year 2025 in support of maintaining the nation's nuclear weapons stockpile and its deterrence mission.
Beck commended the teams for their accomplishment, highlighting their sense of urgency in completing NNSA's mission critical work and the need to continue working with that sense of urgency in support of securing the nation's nuclear deterrent.
"Savannah River Site's work is increasingly vital to our nation's deterrence mission, and every member of this team is making a meaningful difference," said Beck. "You are part of an enterprise that is deterring our adversaries in a major way. We must deliver results with greater speed and urgency, and you are helping us do exactly that. Thank you for your commitment to this mission and for the important work you are doing to strengthen our nation's nuclear deterrent."
Established in 1982, the Defense Program Awards of Excellence are presented annually to honor significant individual and team achievements in quality, productivity, cost savings, safety and innovation supporting the nation's nuclear weapons and stockpile stewardship programs.
SRS teams recognized during the ceremony include:
Savannah River Tritium Enterprise (SRTE) Calendar Year (CY) 2025 Outage
SRTE completed the year-long CY25 Outage, replacing Cold War-era equipment critical to sustaining the nation's tritium supply, which is essential to the nation's nuclear deterrent. The team replaced chillers, compressors, hydride beds, and other major components, maneuvering large systems through restricted access points inside an operating nuclear facility. The outage delivered more than 560,000 work hours and modernized the H Area New Manufacturing facility, strengthening the nation's nuclear deterrent.
SRTE Tritium Extraction Facility (TEF) 2025-2026 Extractions
The SRTE TEF Team achieved a record-breaking production of 13 tritium extractions in just nine months across fiscal years 2025-2026. This accomplishment included extracting more than 3,000 TPBARs, processing six Legal Weight Truck cask shipments and two waste containers, and refurbishing 10 cutterheads--each essential to sustaining and advancing tritium extraction capabilities. Together, these efforts are critical to maintaining the readiness of the U.S. nuclear deterrent and ensuring the long-term availability of the nation's tritium supply.
High-Fidelity Training and Operations Center (HFTOC) Finalized Critical Decision (CD)-2/3 Package
The Savannah River Plutonium Processing Facility (SRPPF) project team finalized the HFTOC CD-2/3 package in less than nine months, advancing the plutonium pit production mission through design completion of the specialized prototyping and training facility. By rapidly incorporating review recommendations, the team completed the design ahead of schedule while accelerating a portion of CD 3X construction. Strategic glovebox conversions and supplier transitions reduced costs and improved long-term schedule performance for pit production, allowing for faster production in the future.
"These accomplishments demonstrate the exceptional expertise, teamwork and commitment of our SRS workforce. From modernizing critical infrastructure to advancing tritium extraction and supporting the nation's plutonium pit production mission, these teams are delivering with urgency and purpose. Their achievements are a testament to the vital role we play in strengthening national security and deterrence during an increasingly complex global environment," said SRNS President and CEO Jeff Griffin.
Following the ceremony, Beck toured key NNSA facilities and engaged in briefings with leaders from the NNSA Savannah River Field Office and Savannah River Nuclear Solutions (SRNS), the managing and operating contractor for SRS.
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Original text here: https://public.srs.gov/2026/10/srs-teams-honored-with-defense-programs-award-of-excellence/
SEC Files Proposed Final Judgment Against Defendant Charged in Alleged Penny Stock Manipulation Scheme
WASHINGTON, Oct. 22 (TNSdock) -- The Securities and Exchange Commission issued the following litigation release:
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Securities and Exchange Commission v. Benjamin Conde, et al., No. 19-cv-05404 (E.D.N.Y. filed Sept. 23, 2019)
On October 20, 2026, the Securities and Exchange Commission filed a proposed final judgment against Benjamin Conde in the U.S. District Court for the Eastern District of New York in connection with an alleged fraudulent scheme to manipulate the market for the securities of Renewable Energy and Power, Inc. ("RBNW").
According to the SEC's complaint, filed on September ... Show Full Article WASHINGTON, Oct. 22 (TNSdock) -- The Securities and Exchange Commission issued the following litigation release: * * * Securities and Exchange Commission v. Benjamin Conde, et al., No. 19-cv-05404 (E.D.N.Y. filed Sept. 23, 2019) On October 20, 2026, the Securities and Exchange Commission filed a proposed final judgment against Benjamin Conde in the U.S. District Court for the Eastern District of New York in connection with an alleged fraudulent scheme to manipulate the market for the securities of Renewable Energy and Power, Inc. ("RBNW"). According to the SEC's complaint, filed on September23, 2019, Conde orchestrated a scheme between March and July 2017 to manipulate the market price and trading volume of RBNW securities. The complaint alleged that Conde acquired millions of shares of RBNW, funded and coordinated a promotional campaign through a boiler room operation, and engaged in matched and wash trading designed to create the false appearance of active trading and artificially inflate the stock price. The complaint further alleged that Conde profited from the scheme by selling shares into the manipulated market at artificially high prices, causing substantial losses to retail investors.
In a parallel criminal action, Conde pleaded guilty to, among other charges, conspiracy to commit securities fraud.
Conde consented to the entry of a final judgment, subject to court approval, that would permanently enjoin him from violating the antifraud provisions of Section 17(a)(1) and (3) of the Securities Act of 1933 and Section 10(b) of the Securities Exchange Act of 1934 and Rules 10b-5(a) and (c) thereunder, as well as the market manipulation provisions of Section 9(a)(1) of the Exchange Act; impose a penny stock bar; and order Conde to pay disgorgement of $1,097,800 and prejudgment interest of $1,681,021.69, for a total of $2,778,821.69, which would be deemed satisfied by the restitution and forfeiture orders entered against him in the parallel criminal case. The final judgment against Conde, and the Commission's voluntary dismissal of its claims against Relief Defendants Essex Global Investment Corp. and Facultas Capital Management, Inc., concludes the litigation.
The SEC's investigation was conducted by Andrew Elliott and Cecilia Connor. The litigation was handled by James E. Smith and Matthew F. Scarlato and supervised by James Carlson. The SEC appreciates the assistance of the U.S. Attorney's Office for the Eastern District of New York, the Federal Bureau of Investigation, and the Financial Industry Regulatory Authority.
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Resources
* Final Judgment (https://www.sec.gov/files/litigation/litreleases/2026/judg26677.pdf)
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Original text here: https://www.sec.gov/enforcement-litigation/litigation-releases/lr-26677
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Securities and Exchange Commission v. Benjamin Conde, et al., No. 19-cv-05404 (E.D.N.Y. filed Sept. 23, 2019)
On October 20, 2026, the Securities and Exchange Commission filed a proposed final judgment against Benjamin Conde in the U.S. District Court for the Eastern District of New York in connection with an alleged fraudulent scheme to manipulate the market for the securities of Renewable Energy and Power, Inc. ("RBNW").
According to the SEC's complaint, filed on September ... Show Full Article WASHINGTON, Oct. 22 (TNSdock) -- The Securities and Exchange Commission issued the following litigation release: * * * Securities and Exchange Commission v. Benjamin Conde, et al., No. 19-cv-05404 (E.D.N.Y. filed Sept. 23, 2019) On October 20, 2026, the Securities and Exchange Commission filed a proposed final judgment against Benjamin Conde in the U.S. District Court for the Eastern District of New York in connection with an alleged fraudulent scheme to manipulate the market for the securities of Renewable Energy and Power, Inc. ("RBNW"). According to the SEC's complaint, filed on September23, 2019, Conde orchestrated a scheme between March and July 2017 to manipulate the market price and trading volume of RBNW securities. The complaint alleged that Conde acquired millions of shares of RBNW, funded and coordinated a promotional campaign through a boiler room operation, and engaged in matched and wash trading designed to create the false appearance of active trading and artificially inflate the stock price. The complaint further alleged that Conde profited from the scheme by selling shares into the manipulated market at artificially high prices, causing substantial losses to retail investors.
In a parallel criminal action, Conde pleaded guilty to, among other charges, conspiracy to commit securities fraud.
Conde consented to the entry of a final judgment, subject to court approval, that would permanently enjoin him from violating the antifraud provisions of Section 17(a)(1) and (3) of the Securities Act of 1933 and Section 10(b) of the Securities Exchange Act of 1934 and Rules 10b-5(a) and (c) thereunder, as well as the market manipulation provisions of Section 9(a)(1) of the Exchange Act; impose a penny stock bar; and order Conde to pay disgorgement of $1,097,800 and prejudgment interest of $1,681,021.69, for a total of $2,778,821.69, which would be deemed satisfied by the restitution and forfeiture orders entered against him in the parallel criminal case. The final judgment against Conde, and the Commission's voluntary dismissal of its claims against Relief Defendants Essex Global Investment Corp. and Facultas Capital Management, Inc., concludes the litigation.
The SEC's investigation was conducted by Andrew Elliott and Cecilia Connor. The litigation was handled by James E. Smith and Matthew F. Scarlato and supervised by James Carlson. The SEC appreciates the assistance of the U.S. Attorney's Office for the Eastern District of New York, the Federal Bureau of Investigation, and the Financial Industry Regulatory Authority.
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Resources
* Final Judgment (https://www.sec.gov/files/litigation/litreleases/2026/judg26677.pdf)
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Original text here: https://www.sec.gov/enforcement-litigation/litigation-releases/lr-26677
FDA Center for Tobacco Products Issues Warning Letter to Snuskompagniet.com
WASHINGTON, Oct. 22 (TNSdock) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to snuskompagniet.com from its Center for Tobacco Products:
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Recipient: snuskompagniet.com, United States, info@snuskompagniet.com
Issuing Office: Center for Tobacco Products, United States
WARNING LETTER
To Whom It May Concern:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://snuskompagniet.com and determined that nicotine pouch products listed there are offered for sale ... Show Full Article WASHINGTON, Oct. 22 (TNSdock) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to snuskompagniet.com from its Center for Tobacco Products: * * * Recipient: snuskompagniet.com, United States, info@snuskompagniet.com Issuing Office: Center for Tobacco Products, United States WARNING LETTER To Whom It May Concern: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://snuskompagniet.com and determined that nicotine pouch products listed there are offered for saleor distribution to consumers in the United States.
Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. Sec. 321(rr)), these products are tobacco products because they are made or derived from tobacco or contain nicotine from any source, and are intended for human consumption./1 Certain tobacco products, including nicotine pouch products, are subject to FDA jurisdiction under section 901 of the FD&C Act (21 U.S.C. Sec. 387a) and 21 C.F.R. Sec. 1100.1, and are required to be in compliance with the requirements in the FD&C Act. Under section 906(d)(5) of the FD&C Act (21 U.S.C. Sec. 387f(d)(5)), it is unlawful for any retailer/2 to sell a tobacco product to any person younger than 21 years of age./3 This includes tobacco products containing nicotine from any source including cigarettes, smokeless tobacco, cigars, e-cigarettes, and nicotine pouches.
Tobacco Product Sold by a Retailer to an Individual Under the Age of 21 is Misbranded
Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. Sec. 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed by any retailer to a person younger than 21 years of age in violation of section 906(d)(5) of the FD&C Act (21 U.S.C. Sec. 387f(d)(5)). FDA has determined that your FIX Watermelon Ice #5 nicotine pouch product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. Sec. 387c(a)(7)(B)) because this product was sold to a person younger than 21 years of age. Specifically, during FDA's investigation of https://snuskompagniet.com, a person younger than 21 years of age purchased FIX Watermelon Ice #5 nicotine pouch product from your website.
Conclusion and Requested Actions
It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA's implementing regulations. Failure to address any violations of the FD&C Act, 21 U.S.C. Sec. 301 et seq., and FDA's implementing regulations, including those in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction. Please note that tobacco products offered for import into the United States that appear to be adulterated or misbranded may be detained or refused admission.
Please be aware that the FD&C Act requires "new tobacco products" to have premarket authorization. A "new tobacco product" is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007. See Section 910(a) of the FD&C Act. For a list of all products that have been authorized by the FDA and certain others that may be legally marketed, please visit the Searchable Tobacco Products Database: https://www.fda.gov/searchtobacco.
You should take prompt action to address the violations that are referenced above, as well as any violations of the FD&C Act and FDA's implementing regulations that are the same as or similar to the ones stated above, and take any necessary actions to bring all your tobacco products into compliance with the FD&C Act.
Please submit a written response to this letter within 15 working days from the date of receipt describing your actions to address any violations and bring your products into compliance, including the dates on which you discontinued the violative labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. This letter notifies you of our findings and provides you with an opportunity to address them. You can find the FD&C Act through links on FDA's homepage at https://www.fda.gov.
Please note your reference number, RW2602442, in your response and direct your response via email at CTPCompliance@fda.hhs.gov and to the following address:
DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
If you have any questions about the content of this letter, please contact CTPCompliance@fda.hhs.gov.
Sincerely,
/S/ Jill Atencio, Acting Director, Office of Compliance and Enforcement, Center for Tobacco Products
VIA Electronic Mail
cc:
YEMAO Company Limited
info@yemao-company.com
Squarespace Domains II LLC
abuse-complaints@squarespace.com
Shopify, Inc.
abuse@shopify.com
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Footnotes:
1/ Effective April 14, 2022, an amendment to the FD&C Act extends FDA's regulation of tobacco products to those containing nicotine from any source. For more information, please see, https://www.fda.gov/tobacco-products/ctp-newsroom/requirements-products-made-non-tobacco-nicotine-take-effect-april-14.
2/ The term 'retailer' means any person, government, or entity who sells tobacco products to individuals for personal consumption, or who operates a facility where self-service displays of tobacco products are permitted. Section 900(14) of the FD&C Act (21 U.S.C. Sec. 387(14)).
3/ Effective December 20, 2019, an amendment to the FD&C Act raises the minimum age of sale of tobacco products to age 21. For more information, please see https://www.fda.gov/tobacco-products/retail-sales-tobacco-products/tobacco-21.
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/snuskompagnietcom-739499-10082026
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Recipient: snuskompagniet.com, United States, info@snuskompagniet.com
Issuing Office: Center for Tobacco Products, United States
WARNING LETTER
To Whom It May Concern:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://snuskompagniet.com and determined that nicotine pouch products listed there are offered for sale ... Show Full Article WASHINGTON, Oct. 22 (TNSdock) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to snuskompagniet.com from its Center for Tobacco Products: * * * Recipient: snuskompagniet.com, United States, info@snuskompagniet.com Issuing Office: Center for Tobacco Products, United States WARNING LETTER To Whom It May Concern: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://snuskompagniet.com and determined that nicotine pouch products listed there are offered for saleor distribution to consumers in the United States.
Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. Sec. 321(rr)), these products are tobacco products because they are made or derived from tobacco or contain nicotine from any source, and are intended for human consumption./1 Certain tobacco products, including nicotine pouch products, are subject to FDA jurisdiction under section 901 of the FD&C Act (21 U.S.C. Sec. 387a) and 21 C.F.R. Sec. 1100.1, and are required to be in compliance with the requirements in the FD&C Act. Under section 906(d)(5) of the FD&C Act (21 U.S.C. Sec. 387f(d)(5)), it is unlawful for any retailer/2 to sell a tobacco product to any person younger than 21 years of age./3 This includes tobacco products containing nicotine from any source including cigarettes, smokeless tobacco, cigars, e-cigarettes, and nicotine pouches.
Tobacco Product Sold by a Retailer to an Individual Under the Age of 21 is Misbranded
Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. Sec. 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed by any retailer to a person younger than 21 years of age in violation of section 906(d)(5) of the FD&C Act (21 U.S.C. Sec. 387f(d)(5)). FDA has determined that your FIX Watermelon Ice #5 nicotine pouch product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. Sec. 387c(a)(7)(B)) because this product was sold to a person younger than 21 years of age. Specifically, during FDA's investigation of https://snuskompagniet.com, a person younger than 21 years of age purchased FIX Watermelon Ice #5 nicotine pouch product from your website.
Conclusion and Requested Actions
It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA's implementing regulations. Failure to address any violations of the FD&C Act, 21 U.S.C. Sec. 301 et seq., and FDA's implementing regulations, including those in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction. Please note that tobacco products offered for import into the United States that appear to be adulterated or misbranded may be detained or refused admission.
Please be aware that the FD&C Act requires "new tobacco products" to have premarket authorization. A "new tobacco product" is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007. See Section 910(a) of the FD&C Act. For a list of all products that have been authorized by the FDA and certain others that may be legally marketed, please visit the Searchable Tobacco Products Database: https://www.fda.gov/searchtobacco.
You should take prompt action to address the violations that are referenced above, as well as any violations of the FD&C Act and FDA's implementing regulations that are the same as or similar to the ones stated above, and take any necessary actions to bring all your tobacco products into compliance with the FD&C Act.
Please submit a written response to this letter within 15 working days from the date of receipt describing your actions to address any violations and bring your products into compliance, including the dates on which you discontinued the violative labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. This letter notifies you of our findings and provides you with an opportunity to address them. You can find the FD&C Act through links on FDA's homepage at https://www.fda.gov.
Please note your reference number, RW2602442, in your response and direct your response via email at CTPCompliance@fda.hhs.gov and to the following address:
DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
If you have any questions about the content of this letter, please contact CTPCompliance@fda.hhs.gov.
Sincerely,
/S/ Jill Atencio, Acting Director, Office of Compliance and Enforcement, Center for Tobacco Products
VIA Electronic Mail
cc:
YEMAO Company Limited
info@yemao-company.com
Squarespace Domains II LLC
abuse-complaints@squarespace.com
Shopify, Inc.
abuse@shopify.com
* * *
Footnotes:
1/ Effective April 14, 2022, an amendment to the FD&C Act extends FDA's regulation of tobacco products to those containing nicotine from any source. For more information, please see, https://www.fda.gov/tobacco-products/ctp-newsroom/requirements-products-made-non-tobacco-nicotine-take-effect-april-14.
2/ The term 'retailer' means any person, government, or entity who sells tobacco products to individuals for personal consumption, or who operates a facility where self-service displays of tobacco products are permitted. Section 900(14) of the FD&C Act (21 U.S.C. Sec. 387(14)).
3/ Effective December 20, 2019, an amendment to the FD&C Act raises the minimum age of sale of tobacco products to age 21. For more information, please see https://www.fda.gov/tobacco-products/retail-sales-tobacco-products/tobacco-21.
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/snuskompagnietcom-739499-10082026
FDA Center for Tobacco Products Issues Warning Letter to Snusi.net
WASHINGTON, Oct. 22 (TNSdock) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to snusi.net from its Center for Tobacco Products:
* * *
Recipient: snusi.net, Sweden, info@snusi.net
Issuing Office: Center for Tobacco Products, United States
WARNING LETTER
To Whom It May Concern:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://snusi.net and determined that nicotine pouch products listed there are offered for sale or distribution to consumers in the United ... Show Full Article WASHINGTON, Oct. 22 (TNSdock) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to snusi.net from its Center for Tobacco Products: * * * Recipient: snusi.net, Sweden, info@snusi.net Issuing Office: Center for Tobacco Products, United States WARNING LETTER To Whom It May Concern: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://snusi.net and determined that nicotine pouch products listed there are offered for sale or distribution to consumers in the UnitedStates.
Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. Sec. 321(rr)), these products are tobacco products because they are made or derived from tobacco or contain nicotine from any source, and are intended for human consumption./1 Certain tobacco products, including nicotine pouch products, are subject to FDA jurisdiction under section 901 of the FD&C Act (21 U.S.C. Sec. 387a) and 21 C.F.R. Sec. 1100.1, and are required to be in compliance with the requirements in the FD&C Act. Under section 906(d)(5) of the FD&C Act (21 U.S.C. Sec. 387f(d)(5)), it is unlawful for any retailer/2 to sell a tobacco product to any person younger than 21 years of age./3 This includes tobacco products containing nicotine from any source including cigarettes, smokeless tobacco, cigars, e-cigarettes, and nicotine pouches.
Tobacco Product Sold by a Retailer to an Individual Under the Age of 21 is Misbranded
Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. Sec. 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed by any retailer to a person younger than 21 years of age in violation of section 906(d)(5) of the FD&C Act (21 U.S.C. Sec. 387f(d)(5)). FDA has determined that your ICEBERG Grape Gum nicotine pouch product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. Sec. 387c(a)(7)(B)) because this product was sold to a person younger than 21 years of age. Specifically, during FDA's investigation of https://snusi.net, a person younger than 21 years of age purchased ICEBERG Grape Gum nicotine pouch product from your website.
Conclusion and Requested Actions
It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA's implementing regulations. Failure to address any violations of the FD&C Act, 21 U.S.C. Sec. 301 et seq., and FDA's implementing regulations, including those in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction. Please note that tobacco products offered for import into the United States that appear to be adulterated or misbranded may be detained or refused admission.
Please be aware that the FD&C Act requires "new tobacco products" to have premarket authorization. A "new tobacco product" is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007. See Section 910(a) of the FD&C Act. For a list of all products that have been authorized by the FDA and certain others that may be legally marketed, please visit the Searchable Tobacco Products Database: https://www.fda.gov/searchtobacco.
You should take prompt action to address the violations that are referenced above, as well as any violations of the FD&C Act and FDA's implementing regulations that are the same as or similar to the ones stated above, and take any necessary actions to bring all your tobacco products into compliance with the FD&C Act.
Please submit a written response to this letter within 15 working days from the date of receipt describing your actions to address any violations and bring your products into compliance, including the dates on which you discontinued the violative labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. This letter notifies you of our findings and provides you with an opportunity to address them. You can find the FD&C Act through links on FDA's homepage at https://www.fda.gov.
Please note your reference number, RW2602441, in your response and direct your response via email at CTPCompliance@fda.hhs.gov and to the following address:
DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
If you have any questions about the content of this letter, please contact CTPCompliance@fda.hhs.gov.
Sincerely,
/S/ Jill Atencio, Acting Director, Office of Compliance and Enforcement, Center for Tobacco Products
VIA Electronic Mail
cc:
Contact Privacy Inc.
snusi.net@contactprivacy.com
Tucows Domains Inc.
domainabuse@tucows.com
Shopify, Inc.
abuse@shopify.com
* * *
Footnotes:
1/ Effective April 14, 2022, an amendment to the FD&C Act extends FDA's regulation of tobacco products to those containing nicotine from any source. For more information, please see, https://www.fda.gov/tobacco-products/ctp-newsroom/requirements-products-made-non-tobacco-nicotine-take-effect-april-14.
2/ The term 'retailer' means any person, government, or entity who sells tobacco products to individuals for personal consumption, or who operates a facility where self-service displays of tobacco products are permitted. Section 900(14) of the FD&C Act (21 U.S.C. Sec. 387(14)).
3/ Effective December 20, 2019, an amendment to the FD&C Act raises the minimum age of sale of tobacco products to age 21. For more information, please see https://www.fda.gov/tobacco-products/retail-sales-tobacco-products/tobacco-21.
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/snusinet-739447-10082026
* * *
Recipient: snusi.net, Sweden, info@snusi.net
Issuing Office: Center for Tobacco Products, United States
WARNING LETTER
To Whom It May Concern:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://snusi.net and determined that nicotine pouch products listed there are offered for sale or distribution to consumers in the United ... Show Full Article WASHINGTON, Oct. 22 (TNSdock) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to snusi.net from its Center for Tobacco Products: * * * Recipient: snusi.net, Sweden, info@snusi.net Issuing Office: Center for Tobacco Products, United States WARNING LETTER To Whom It May Concern: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://snusi.net and determined that nicotine pouch products listed there are offered for sale or distribution to consumers in the UnitedStates.
Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. Sec. 321(rr)), these products are tobacco products because they are made or derived from tobacco or contain nicotine from any source, and are intended for human consumption./1 Certain tobacco products, including nicotine pouch products, are subject to FDA jurisdiction under section 901 of the FD&C Act (21 U.S.C. Sec. 387a) and 21 C.F.R. Sec. 1100.1, and are required to be in compliance with the requirements in the FD&C Act. Under section 906(d)(5) of the FD&C Act (21 U.S.C. Sec. 387f(d)(5)), it is unlawful for any retailer/2 to sell a tobacco product to any person younger than 21 years of age./3 This includes tobacco products containing nicotine from any source including cigarettes, smokeless tobacco, cigars, e-cigarettes, and nicotine pouches.
Tobacco Product Sold by a Retailer to an Individual Under the Age of 21 is Misbranded
Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. Sec. 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed by any retailer to a person younger than 21 years of age in violation of section 906(d)(5) of the FD&C Act (21 U.S.C. Sec. 387f(d)(5)). FDA has determined that your ICEBERG Grape Gum nicotine pouch product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. Sec. 387c(a)(7)(B)) because this product was sold to a person younger than 21 years of age. Specifically, during FDA's investigation of https://snusi.net, a person younger than 21 years of age purchased ICEBERG Grape Gum nicotine pouch product from your website.
Conclusion and Requested Actions
It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA's implementing regulations. Failure to address any violations of the FD&C Act, 21 U.S.C. Sec. 301 et seq., and FDA's implementing regulations, including those in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction. Please note that tobacco products offered for import into the United States that appear to be adulterated or misbranded may be detained or refused admission.
Please be aware that the FD&C Act requires "new tobacco products" to have premarket authorization. A "new tobacco product" is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007. See Section 910(a) of the FD&C Act. For a list of all products that have been authorized by the FDA and certain others that may be legally marketed, please visit the Searchable Tobacco Products Database: https://www.fda.gov/searchtobacco.
You should take prompt action to address the violations that are referenced above, as well as any violations of the FD&C Act and FDA's implementing regulations that are the same as or similar to the ones stated above, and take any necessary actions to bring all your tobacco products into compliance with the FD&C Act.
Please submit a written response to this letter within 15 working days from the date of receipt describing your actions to address any violations and bring your products into compliance, including the dates on which you discontinued the violative labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. This letter notifies you of our findings and provides you with an opportunity to address them. You can find the FD&C Act through links on FDA's homepage at https://www.fda.gov.
Please note your reference number, RW2602441, in your response and direct your response via email at CTPCompliance@fda.hhs.gov and to the following address:
DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
If you have any questions about the content of this letter, please contact CTPCompliance@fda.hhs.gov.
Sincerely,
/S/ Jill Atencio, Acting Director, Office of Compliance and Enforcement, Center for Tobacco Products
VIA Electronic Mail
cc:
Contact Privacy Inc.
snusi.net@contactprivacy.com
Tucows Domains Inc.
domainabuse@tucows.com
Shopify, Inc.
abuse@shopify.com
* * *
Footnotes:
1/ Effective April 14, 2022, an amendment to the FD&C Act extends FDA's regulation of tobacco products to those containing nicotine from any source. For more information, please see, https://www.fda.gov/tobacco-products/ctp-newsroom/requirements-products-made-non-tobacco-nicotine-take-effect-april-14.
2/ The term 'retailer' means any person, government, or entity who sells tobacco products to individuals for personal consumption, or who operates a facility where self-service displays of tobacco products are permitted. Section 900(14) of the FD&C Act (21 U.S.C. Sec. 387(14)).
3/ Effective December 20, 2019, an amendment to the FD&C Act raises the minimum age of sale of tobacco products to age 21. For more information, please see https://www.fda.gov/tobacco-products/retail-sales-tobacco-products/tobacco-21.
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/snusinet-739447-10082026
FDA Center for Drug Evaluation & Research Issues Warning Letter to Baxter International
WASHINGTON, Oct. 22 (TNSdock) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Baxter International Inc. from its Center for Drug Evaluation and Research:
* * *
Recipient: Mr. Andrew Hider, President and CEO, Baxter International Inc., One Baxter Parkway, Deerfield, IL 60015, United States
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
Reference number: 320-26-132
To Andrew Hider:
This warning letter advises you of significant violations observed during a U.S. Food and Drug ... Show Full Article WASHINGTON, Oct. 22 (TNSdock) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Baxter International Inc. from its Center for Drug Evaluation and Research: * * * Recipient: Mr. Andrew Hider, President and CEO, Baxter International Inc., One Baxter Parkway, Deerfield, IL 60015, United States Issuing Office: Center for Drug Evaluation and Research (CDER), United States WARNING LETTER Reference number: 320-26-132 To Andrew Hider: This warning letter advises you of significant violations observed during a U.S. Food and DrugAdministration (FDA) inspection of your facility. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
FDA Inspection
Violations were observed and documented during an inspection of your drug manufacturing facility, Baxter Healthcare Corporation, FDA Establishment Identifier (FEI) 1416980, at 25212 W Illinois Route 120, Round Lake, from March 23 to April 2, 2026. This inspection was conducted under FDA's statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your April 23, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.
Violations of the Federal Food, Drug, and Cosmetic Act
The following are violations identified during our inspection and review. As a reminder, this is not an all-inclusive list of violations at your facility.
1. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(c)).
You manufacture various injectable drugs products including cephalosporins (a beta-lactam drug product) and (b)(4) drug products at your facility. You failed to ensure complete and comprehensive separation of cephalosporin and (b)(4) drug products in this shared facility.
Lack of Complete and Comprehensive Separation
Your facilities and controls were inadequate to prevent the conditions that would allow for cephalosporin contamination of (b)(4) drugs.
Your building is divided into (b)(4) beta lactams, (b)(4) production. These building segments are separated by a physical wall that you consider to be fully sealed, along with dedicated HVAC units.
However, since January 2025, your environmental monitoring (EM) program used to monitor containment of beta-lactam drug products has detected cephalosporin in several instances and in multiple areas of the (b)(4) side of the building.
Inadequate Cephalosporin Monitoring
While your monitoring program detected recurring cross-contamination, it was inadequate to promptly detect loss of containment and cephalosporin contamination in your facility. For example:
* EM sampling was insufficient in both number and location.
* Swab sampling qualification was inadequate to assure low-level recovery.
* Samples were evaluated beyond established solution stability time allowances.
These inadequacies create risk for underrepresentation of true contamination hazards throughout your facility, create potential for false negative results, and inhibit meaningful data collection upon which your quality unit (QU) can make sound risk-based decisions.
A rigorous monitoring program is essential for facility qualification, early detection of contamination hazards, and timely corrective action and preventive action (CAPA).
In addition, your testing of (b)(4) drug products for potential contamination consisted of a single unit regardless of batch size. However, contamination is generally nonuniformly distributed. Results obtained from testing a small sample size are unlikely to detect contamination that may exist in a batch exposed to the contamination hazards identified at your firm. Consequently, substantial residual uncertainty remains regarding the actual variability of contamination that may exist in batches you produce.
We also note that you mistakenly discarded multiple failing cephalosporin environmental samples before further analysis could be conducted.
In your response, you commit to strengthen investigations into positive cephalosporin findings, create a tracking form to help prevent missed samples, and improve low-level recovery. Your response also indicates that significant uncertainty remains regarding the causes of the recurring findings of facility contamination. You indicate that personnel movement was a weakness in your containment strategy while adding that personnel movement is likely not the sole contributing factor.
Your response is inadequate because it fails to adequately address how you will ensure complete and comprehensive separation. You also failed to thoroughly reevaluate your original risk management decisions, including supportive risk assessments and associated risk controls, to ensure prevention of beta-lactam cross-contamination. Although your cephalosporin and (b)(4) areas exist within the same external building structure that you claim is completely and comprehensively separated by a (b)(4), it is essential that your design completely precludes any potential for incidental air, personnel, materials, equipment, or other interaction that could be a vector of contamination. A rigorous quality risk management program should comprehensively assess the design and determine if it provides as much protection against cross-contamination as is achieved by manufacturing in a separate building.
We note that data shared during our recall discussions revealed additional cephalosporin contamination events in the (b)(4) area, including as recently as (b)(4).
Contamination of (b)(4) with beta-lactam drugs presents a serious risk to patient safety, including potential life-threatening (b)(4). (b)(4) responses can occur in susceptible patients exposed to (b)(4) beta-lactams. Therefore, no safe level of beta-lactam contamination has been determined to be a tolerable risk.
In response to this letter, provide:
* A comprehensive, independent evaluation of the sufficiency of facility modifications implemented in an attempt to achieve complete and comprehensive separation (e.g., physical wall, dedicated air handling) between cephalosporin and (b)(4) areas.
* An updated comprehensive, independent risk assessment of all beta-lactam contamination hazards with respect to your procedures, equipment, and facilities, including but not limited to, the following:
- Identification of all contamination hazards (e.g., personnel, material, air systems, infrastructure vulnerabilities).
- Hazard identification using formal hazard identification tools.
- Expanded risk-based EM including appropriate, scientifically justified, sampling methods, locations, and frequencies (e.g., inside production rooms, equipment surfaces, walls, contractor and operator garments, boots, shared forklifts trucks, shared lab cabinet, other potential cross-contamination locations), with consideration of all associated containment elements.
- More responsive systems to vigilantly respond to any contamination, including enhanced trending systems.
- Personnel flow and material flow (comprehensive mapping of all such potential interactions between all facilities that may introduce a potential hazard).
- Scientifically justified sampling of (b)(4) finished drug product batches.
- Specific CAPA recommendations that will comprehensively address the design and control hazards identified in the risk assessment.
* A detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe specific tangible improvements to be made to design (e.g., facility changes) and explain how this CAPA plan will robustly remediate your deficiencies. Include a description of any residual risk that may remain following these remediations, and describe whether it enables risk acceptance. Also include a commitment to implement thorough change effectiveness activities and to revisit the risk assessment when necessary.
* A comprehensive assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm's documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous (ALCOA) records throughout your operation.
* Full investigations and data pertaining to any failing cephalosporin samples that were discarded since August 2024, including but not limited to sampling location, date, recovery amount, and any extra testing that was to be performed.
2. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). Your firm also failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)).
You operate (b)(4) processing lines used to aseptically manufacture sterile injectable drug products for the U.S. market. Your (b)(4) were inadequately validated to ensure that they were capable of consistently (b)(4) interior surfaces of your (b)(4) lines in preparation for aseptic production. In addition, your aseptic process simulations did not sufficiently represent worst-case conditions, and you lacked adequate sampling of your ISO 5 (Grade A) area.
Biological Indicator Recoveries and Inadequate (b)(4) Validation
Inadequacies in your (b)(4) process were demonstrated through a trend of routine recoveries of biological indicator (BI) growth at the completion of (b)(4) cycle re-qualification (validation) runs since (b)(4).
Notably, your acceptance criteria were inappropriate in that they allowed routine recovery of multiple BI survivors per re-qualification run. An adverse trend of numerous positive BIs were identified in multiple re-qualification cycles across multiple (b)(4) lines. For example, for line (b)(4), positive BIs occurred at numerous locations ((b)(4) of (b)(4) locations) and the positive findings included multiple replicates per location ((b)(4) recoveries of (b)(4) replicates). In addition, other lines had similar substantial findings of positive BIs. However, you considered all re-qualification studies to be acceptable and did not further evaluate the excessive variability of your (b)(4), including the potential impact to product. These significant recurring BI failures indicate poor (b)(4) method efficacy and require further investigation.
We also noted additional deficiencies in your (b)(4) reliability. For example:
* You lacked adequate scientific justification for BI locations.
* You allowed repetition of re-qualification cycles without proper investigation into observed BI growth.
* You did not align with technical references you cited in your procedures.
We note that you recovered (b)(4), from an (b)(4) inside your (b)(4) during production.
In your response, you commit to engaging a (b)(4) to help improve (b)(4), revising acceptance criteria to align with industry standards, and initiating non-conformance reports to investigate the observed BI growth. You also commit to evaluating alternative (b)(4) technology.
Your response is inadequate in that it does not provide sufficient detail or supporting documentation to describe how adequate (b)(4) will be achieved during the interim period prior to completion of long-term remediation.
Incomplete exposure of interior surfaces to (b)(4) compromises (b)(4) effectiveness and places your (b)(4) environment at risk. The (b)(4) (Grade A) area is critical because sterile products are exposed during aseptic production and therefore vulnerable to contamination if operations are not well designed and diligently controlled. Aseptic processing operations should be designed and executed to minimize exposure of sterile articles to potential contamination hazards in the manufacturing operation. Flaws in the design or control of cleanrooms and aseptic processing operations can enable entry of contaminants into the critical (b)(4) processing area and lead to product contamination.
Inadequate Aseptic Process Simulation
The intervention of (b)(4) was simulated approximately (b)(4) times during a media fill, but production records indicate a significantly higher occurrence of this intervention.
In your response you commit to updating the minimum number of (b)(4) simulations to (b)(4) based on your 2026 retrospective review, which only covered approximately (b)(4). Your response is inadequate as it does not ensure worst-case production activities and conditions are challenged across all (b)(4) lines. If a media fill program fails to incorporate contamination risk factors and closely simulate actual drug production, the state of process control and assurance of sterility cannot be accurately assessed.
Inadequate Environmental Monitoring
Your (b)(4) processing lines include critical operational steps conducted in (b)(4). However, there was only a (b)(4) in one of these (b)(4). In addition, surfaces were not monitored for microbiological contamination.
Vigilant and responsive environmental monitoring programs provide meaningful information on the state of control of the aseptic processing operation and enable an early warning system that identifies emerging contamination hazards before sterility is compromised.
Inadequate Airflow
Although your (b)(4) configurations can vary (e.g., (b)(4) bag capacity, (b)(4) configuration), you lacked airflow visualization studies in (b)(4) of your (b)(4) lines. In addition, your airflow visualization studies were insufficient (e.g., worst-case (b)(4) conditions).
We note that you have had a history of sporadic sterility test positives since 2013 (testing is routinely performed in a (b)(4)) and persistent particulate contamination issues.
Your airflow visualization studies also revealed substantial turbulence in your (b)(4), in which critical process steps are performed. Your firm acknowledged turbulent non-unidirectional airflow within your (b)(4), which houses processing equipment.
Our overall findings indicate significant deficiencies in the design of your aseptic processing operation. Your current equipment, process, and airflow design pose excessive contamination risk.
Turbulent airflow may be appropriate for a (b)(4) that does not house aseptic processing equipment. In contrast, your firm uses (b)(4) that include processing line equipment.
A strong quality system is essential to oversee design and construction of aseptic processing lines, cleanrooms, and supporting utilities, and to ensure ongoing proper operational control to safeguard against contamination hazards throughout the facility lifecycle.
Well-designed aseptic processing (b)(4) represent a significant technological advance over traditional operational designs. Because all technologies have failure modes, it is essential to implement a robust design and control program that enables an ongoing state of control.
See FDA's guidance document Sterile Drug Products Produced by Aseptic Processing--Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing at https://www.fda.gov/media/71026/download.
In your response, you commit to improving your EM program and performing airflow visualization studies on all of your lines. You also state that you will use data from these studies to identify locations for BIs and EM.
Your response is inadequate as you lack a commitment to upgrade your manufacturing infrastructure, including equipment replacement, as part of your long-term remediation plan. In addition, the timeline for implementation of additional viable air monitoring in the (b)(4) is unclear.
In response to this letter, provide:
* A detailed program for designing, validating, maintaining, controlling and monitoring each of your (b)(4) that includes vigilant monitoring to ensure an ongoing state of control.
* A comprehensive, independent risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, including but not limited to, the following:
- All human interactions within the (b)(4) area (e.g., risk reduction or elimination of manual interventions wherever possible)
- Equipment suitability (e.g., reliability, capability, ergonomics, placement) and sufficiency of space for operations
- Air quality in the (b)(4) area including, but not limited to, air unidirectionality
- Facility layout
- Personnel flow and material flow (movement throughout all rooms used to conduct and support sterile operations, and all material transfers)
- (b)(4) practices and procedures (e.g., (b)(4) efficacy, appropriate (b)(4) and configuration)
- Specific CAPA recommendations that will comprehensively address the design and control hazards identified in the risk assessment
* A detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe comprehensive improvements to be made to aseptic processing operation design and control at your facility and explain how this CAPA plan will systematically remediate your deficient sterile manufacturing operations. Include detailed changes to the design of both your aseptic processing lines and cleanrooms. Your action plan should include both an interim plan as well as long-term steps to fully remediate your facility, equipment, and process design.
* An independent review, detailed report, CAPA, and timelines for remediation of your (b)(4) methods (e.g., (b)(4) parameters, optimized airflow, improved surface exposure). This comprehensive, independent analysis should incorporate any differences between the design and operation of each (b)(4) and its processing equipment (e.g., dimensions, orientation, (b)(4) design, air volume, (b)(4), (b)(4) bowls, bag capacity, etc.).
* An independent, comprehensive evaluation of airflow unidirectionality in your aseptic processing operations. Ensure smoke studies are conducted under dynamic conditions with thorough and complete assessments of aseptic processing line airflow unidirectionality, including the impact of aseptic interventions, worst-case (b)(4) pattern, and dynamic interactions with the surrounding cleanroom. Conduct these smoke studies after you remediate your aseptic operation and using proper practices (e.g., (b)(4) media) to appropriately visualize airflow.
* A comprehensive, independent review of your process simulation (e.g., media fill) program to ensure accurate simulations of commercial aseptic manufacturing operations, including, but not limited to, appropriate incorporation of worst-case conditions.
* A summary table of all EM (includes surfaces, air, and (b)(4)) results within your (b)(4) lines that revealed microbial growth since January 1, 2023. Include line sample location, date, colony forming unit (CFU) count, microorganism identification, and any associated investigations.
3. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
Your manual visual inspection program was inadequate to reliably detect defects and ensure your sterile injectable drug products were essentially free of visible particulates.
For example, operators performing (b)(4) visual inspection were not properly qualified, as evidenced by the following:
* Operators were not appropriately challenged to ensure they were capable of reliably detecting particulates within the lower end of the visible spectrum.
* Particulates in challenge kits were excessively large (e.g., greater than (b)(4) microns), approximately (b)(4) times larger than what operators should be capable of reliably detecting.
* Operators' rate of inspection was excessively fast (e.g., (b)(4) per unit) and did not align with the standards referenced in your procedures.
* Notably, you also demonstrated poor detection rates when you used significantly longer inspection times during Acceptable Quality Limit (AQL) sampling.
Your approach to identifying product defects compromises reliable detection and the quality of data inputs to support batch release and CAPA decisions made by your quality unit.
In addition, the significant particulate matter complaints received between 2023 to 2025 indicate an inadequate visual inspection program. For example, on May 9, 2025, after testing a returned cefazolin complainant sample you confirmed foreign particulate contamination was consistent with cardboard (approximately (b)(4) mm). Your investigation concluded that inadequacies of visual inspection were a contributing cause, but you did not implement sufficient CAPA to ensure remediation of your visual inspection program.
Your investigation specifically cited potential for compromised product quality and potential patient safety risks, but stated that field action was not warranted. We acknowledge that on July 17, 2026, you agreed to voluntarily recall cefazolin, Lot LD175708, only after the Agency contacted you.
In your response you commit to enhancing your visual inspection program including performing probability of detection (PoD) studies using the (b)(4) per unit inspection duration.
Your response is inadequate. You indicate that data from post-market complaint evaluations and retain sample reviews confirm that your controls remain effective. However, you have identified particulate matter in retain and complaint samples after product was released. In addition, your response does not adequately address the spike in particulate matter defects from 2024 ((b)(4) defects) to 2025 ((b)(4) defects). There remains a lack of assurance that your injectable drug products are essentially free from visible particulates while you work on long-term remediation.
Visual detection of particulates is a probabilistic process that depends on, among other things, ensuring that visible particulates can be reproducibly detected by trained personnel with appropriate visual acuity. At a minimum, personnel should reliably be capable of detecting particulates of (b)(4) microns or greater at a (b)(4)% probability of detection. It is important that any visible particulate contamination is appropriately evaluated and investigated. Particulates in injectable products should be avoided through appropriate preventive measures built into your design and production controls. When categorizing any visible particles, extrinsic or foreign matter should receive special attention, as it may indicate possible microbial contamination. Extrinsic or foreign particulate contamination should occur very infrequently and trigger a thorough investigation and appropriate CAPA.
In response to this letter, provide:
* A comprehensive, independent assessment and remediation plan of your systems for the visual inspection of sterile injectable drugs for defects, including the presence of particulate matter. The assessment should include acceptance and rejection criteria, personnel training, supervision, equipment and personnel qualification, equipment maintenance, and process validation, and the procedures governing them. Also include product-specific knowledge, process experience (e.g., thorough assessment of the spike of (b)(4) particulate matter defects in 2025), deviation investigation analysis, and recall/complaint data. Provide your detailed remediation action plan that includes dates by which each remediation activity will be completed and a periodic independent reassessment of the plan's effectiveness. Include a summary of the review and recommendations made by your independent consultant.
* A comprehensive, independent assessment of each lot of sterile injectable drugs distributed from your facility that remains within expiry to meet the requirement of being essentially free of visible particles. This comprehensive review should include a review of all relevant in-process and finished product data obtained by your firm including all batch records.
* An interim plan for risk mitigation while you perform broader studies to improve your visual inspection program. Provide a detailed list of your risk mitigations (e.g., sampling plans and methods for your proposed destructive testing).
4. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
There was a pattern of inadequate investigations into critical issues, including leaking drug products and sterility failures.
Leaking Units
Your investigations into the "systemic nature" of container-closure integrity failures lacked effective CAPA to address the significantly increased rate of leak defects in your injectable drug products. You did not implement sufficient CAPA to ensure remediation of your final inspection program. Further, since 2023, media fill units were found leaking during incubation and you have received numerous leak complaints for marketed products.
All sterile drugs must be packaged using container-closure systems with robust protection that prevents the ingress of microorganisms. A product's ability to maintain integrity throughout anticipated stresses and external factors during manufacture, storage, distribution, and consumer use is critical to ensure product quality and safety. Loss of container-closure integrity is a direct cause of non-sterility.
In your response, you acknowledge that strengthening your investigation system is warranted and you will evaluate whether (b)(4) container closure integrity testing (CCIT) could be an effective layered control. You also commit to a retrospective review of critical non-conformance reports (NCR) and laboratory investigations for the last year.
Your response is inadequate. Limiting a retrospective review to (b)(4) lacks adequate scientific justification as your leak trending data illustrated the leak rate has consistently increased annually from 2023 to 2026. You also do not sufficiently address how a lack of highly capable leak detection systems impacts already produced products, or sufficiently detail improvements to your CAPA system. In addition, data from your firm indicates that although leak rate has increased, the number of NCRs opened has decreased.
Sterility Failure
Your investigation into a 2025 sterility failure for cefazolin, lot (b)(4), assigned the root cause as a non-integral test container. Test records had been signed and dated indicating that container integrity was initially verified. However, after observing turbidity, you subsequently stated in your investigation that container integrity was not verified, classifying it as a "no-test." Without conducting a Phase II investigation, you concluded there was no risk to the manufacturing process or finished product. You invalidated the sterility result without adequate scientific justification and released this lot in July 2025.
Notably, the same container integrity problem had been observed in the sterility test of (b)(4), lot (b)(4), in (b)(4), which you rejected.
In addition, a "no-test" designation was used for an (b)(4) cycle requalification attempt that resulted in numerous positive BIs.
In your response, you state your belief that the laboratory error of incubating non-integral sterility test containers was the definitive root cause. Your response is inadequate as it fails to address why your lab records described the test container as integral. It also fails to thoroughly address the lack of contemporaneous documentation of any subsequent deviation that could have theoretically occurred. You also commit to implementing a closed membrane sterility testing system in the future, but your proposal does not ensure timely remediation.
Product contamination may go undetected for substantial periods if your firm employs unreliable sterility testing practices. It should also be noted that any positive sterility test result represents a serious CGMP issue that requires a comprehensive investigation into the cause and extent of the problem, and a prompt review of the qualification status of the aseptic process.
Your firm's quality systems are inadequate. For guidance on establishing and maintaining CGMP-compliant quality systems, see FDA guidance documents: Q8(R2) Pharmaceutical Development at https://www.fda.gov/media/71535/download, Q9(R1) Quality Risk Management at https://www.fda.gov/media/167721/download, and Q10 Pharmaceutical Quality System at https://www.fda.gov/media/71553/download.
In response to this letter, provide:
* A comprehensive assessment and remediation plan to ensure your QU is given the authority, independence, and resources to effectively function. The assessment should also include, but not be limited to, the following:
- A determination of whether procedures used by your firm are robust and appropriate
- Provisions for independent QU oversight throughout your CGMP operations to ensure satisfactory procedures and adherence to appropriate practices
- A complete and final review of each batch and its related information before the QU disposition decision, including all investigations
- Oversight and approval of discharging of all QU duties to ensure identity, strength, quality, and purity of all products
- Also, describe how executive management supports robust quality assurance at your firm, including, but not limited to, timely provision of resources that enable proactive detection and resolution of emerging manufacturing/quality issues to assure a continuing state of control
* A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification results, out-of-limit results, and failures. Provide a detailed action plan to remediate this system, encompassing the following:
- Staff competencies (including use of appropriate subject matter experts)
- Written procedures
- Scientific rigor and foundation
- Scope determination
- Root cause evaluations
- CAPA effectiveness
- Quality unit lead functional roles, and oversight to ensure all phases of investigations are appropriately conducted
- And, based on above, detailed systemic improvements to the investigation system
* An independent third-party assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigation trends, improves the CAPA program when needed, implements final quality unit decisions, and is fully supported by executive management.
* Provide a comprehensive, independent process capability assessment of your aseptic processing lines, with special emphasis on the capability of critical operational steps, including but not limited to, all container-closure integrity failure modes, and any related CAPA to be initiated in response to the capability assessment.
* Perform a holistic assessment across your facilities for similar issues noted at this site and implement appropriate CAPA across your corporate network.
CGMP Consultant
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit1 of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm's compliance status with FDA.
Your use of a consultant does not relieve your firm's obligation to comply with CGMP.
Repeat Observations at Multiple Sites
In a previous regulatory meeting held on January 15, 2025, FDA discussed similar CGMP violations at this facility. You proposed specific remediations for these violations in your response.
FDA also cited similar CGMP violations at other facilities in your company's network. These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate.
Your firm's executive management remains responsible for fully resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance. You should immediately and comprehensively assess your company's global manufacturing operations to ensure that systems, processes, and the products manufactured conform to FDA requirements.
Drug Recall
On July 17, 2026, FDA held a teleconference with your firm and recommended that you voluntarily recall one lot of cefazolin and various (b)(4) drugs currently in distribution from the U.S. market, to which you agreed.
The company announcement for the cardboard particulate recall was posted to the FDA website: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-voluntary-nationwide-recall-cefazolin-dextrose-injection-usp-2g-100ml-20mg-ml-single
Request for a Meeting with FDA
After you submit your response to this warning letter, we recommend that you reach out to this office to arrange for a teleconference to discuss your corrective actions and preventive actions in detail. Direct your request to Kathryn Hall at CDER-OC-OMQ-Communications@fda.hhs.gov.
Conclusion
You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.
Unresolved violations may prevent other Federal agencies from awarding contracts. Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.
If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER's Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356c(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.
Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of receipt of this letter2. Identify your written response with FEI 1416980 and ATTN: Compliance Officer Matthew Schnupp in the letter or in the subject line of the email.
If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.
FDA posts warning letters to www.FDA.gov.
Sincerely,
/S/ Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
cc:
Ivan Quadrio
Site Director and Associate Vice President of Engineering
Baxter Healthcare Corporation
25212 W Il Route 120
Round Lake, IL 60073
Ivan_quadrio@baxter.com
Scott Kaplan
Head of Quality, Regulatory Affairs, and Patient Safety
Baxter Healthcare Corporation
1 Baxter Parkway
Deerfield, IL 60015
scott_kaplan@baxter.com
* * *
Footnotes:
1/ i.e., Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA's guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.
2/ Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/baxter-international-inc-733231-09292026
* * *
Recipient: Mr. Andrew Hider, President and CEO, Baxter International Inc., One Baxter Parkway, Deerfield, IL 60015, United States
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
Reference number: 320-26-132
To Andrew Hider:
This warning letter advises you of significant violations observed during a U.S. Food and Drug ... Show Full Article WASHINGTON, Oct. 22 (TNSdock) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Baxter International Inc. from its Center for Drug Evaluation and Research: * * * Recipient: Mr. Andrew Hider, President and CEO, Baxter International Inc., One Baxter Parkway, Deerfield, IL 60015, United States Issuing Office: Center for Drug Evaluation and Research (CDER), United States WARNING LETTER Reference number: 320-26-132 To Andrew Hider: This warning letter advises you of significant violations observed during a U.S. Food and DrugAdministration (FDA) inspection of your facility. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
FDA Inspection
Violations were observed and documented during an inspection of your drug manufacturing facility, Baxter Healthcare Corporation, FDA Establishment Identifier (FEI) 1416980, at 25212 W Illinois Route 120, Round Lake, from March 23 to April 2, 2026. This inspection was conducted under FDA's statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your April 23, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.
Violations of the Federal Food, Drug, and Cosmetic Act
The following are violations identified during our inspection and review. As a reminder, this is not an all-inclusive list of violations at your facility.
1. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(c)).
You manufacture various injectable drugs products including cephalosporins (a beta-lactam drug product) and (b)(4) drug products at your facility. You failed to ensure complete and comprehensive separation of cephalosporin and (b)(4) drug products in this shared facility.
Lack of Complete and Comprehensive Separation
Your facilities and controls were inadequate to prevent the conditions that would allow for cephalosporin contamination of (b)(4) drugs.
Your building is divided into (b)(4) beta lactams, (b)(4) production. These building segments are separated by a physical wall that you consider to be fully sealed, along with dedicated HVAC units.
However, since January 2025, your environmental monitoring (EM) program used to monitor containment of beta-lactam drug products has detected cephalosporin in several instances and in multiple areas of the (b)(4) side of the building.
Inadequate Cephalosporin Monitoring
While your monitoring program detected recurring cross-contamination, it was inadequate to promptly detect loss of containment and cephalosporin contamination in your facility. For example:
* EM sampling was insufficient in both number and location.
* Swab sampling qualification was inadequate to assure low-level recovery.
* Samples were evaluated beyond established solution stability time allowances.
These inadequacies create risk for underrepresentation of true contamination hazards throughout your facility, create potential for false negative results, and inhibit meaningful data collection upon which your quality unit (QU) can make sound risk-based decisions.
A rigorous monitoring program is essential for facility qualification, early detection of contamination hazards, and timely corrective action and preventive action (CAPA).
In addition, your testing of (b)(4) drug products for potential contamination consisted of a single unit regardless of batch size. However, contamination is generally nonuniformly distributed. Results obtained from testing a small sample size are unlikely to detect contamination that may exist in a batch exposed to the contamination hazards identified at your firm. Consequently, substantial residual uncertainty remains regarding the actual variability of contamination that may exist in batches you produce.
We also note that you mistakenly discarded multiple failing cephalosporin environmental samples before further analysis could be conducted.
In your response, you commit to strengthen investigations into positive cephalosporin findings, create a tracking form to help prevent missed samples, and improve low-level recovery. Your response also indicates that significant uncertainty remains regarding the causes of the recurring findings of facility contamination. You indicate that personnel movement was a weakness in your containment strategy while adding that personnel movement is likely not the sole contributing factor.
Your response is inadequate because it fails to adequately address how you will ensure complete and comprehensive separation. You also failed to thoroughly reevaluate your original risk management decisions, including supportive risk assessments and associated risk controls, to ensure prevention of beta-lactam cross-contamination. Although your cephalosporin and (b)(4) areas exist within the same external building structure that you claim is completely and comprehensively separated by a (b)(4), it is essential that your design completely precludes any potential for incidental air, personnel, materials, equipment, or other interaction that could be a vector of contamination. A rigorous quality risk management program should comprehensively assess the design and determine if it provides as much protection against cross-contamination as is achieved by manufacturing in a separate building.
We note that data shared during our recall discussions revealed additional cephalosporin contamination events in the (b)(4) area, including as recently as (b)(4).
Contamination of (b)(4) with beta-lactam drugs presents a serious risk to patient safety, including potential life-threatening (b)(4). (b)(4) responses can occur in susceptible patients exposed to (b)(4) beta-lactams. Therefore, no safe level of beta-lactam contamination has been determined to be a tolerable risk.
In response to this letter, provide:
* A comprehensive, independent evaluation of the sufficiency of facility modifications implemented in an attempt to achieve complete and comprehensive separation (e.g., physical wall, dedicated air handling) between cephalosporin and (b)(4) areas.
* An updated comprehensive, independent risk assessment of all beta-lactam contamination hazards with respect to your procedures, equipment, and facilities, including but not limited to, the following:
- Identification of all contamination hazards (e.g., personnel, material, air systems, infrastructure vulnerabilities).
- Hazard identification using formal hazard identification tools.
- Expanded risk-based EM including appropriate, scientifically justified, sampling methods, locations, and frequencies (e.g., inside production rooms, equipment surfaces, walls, contractor and operator garments, boots, shared forklifts trucks, shared lab cabinet, other potential cross-contamination locations), with consideration of all associated containment elements.
- More responsive systems to vigilantly respond to any contamination, including enhanced trending systems.
- Personnel flow and material flow (comprehensive mapping of all such potential interactions between all facilities that may introduce a potential hazard).
- Scientifically justified sampling of (b)(4) finished drug product batches.
- Specific CAPA recommendations that will comprehensively address the design and control hazards identified in the risk assessment.
* A detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe specific tangible improvements to be made to design (e.g., facility changes) and explain how this CAPA plan will robustly remediate your deficiencies. Include a description of any residual risk that may remain following these remediations, and describe whether it enables risk acceptance. Also include a commitment to implement thorough change effectiveness activities and to revisit the risk assessment when necessary.
* A comprehensive assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm's documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous (ALCOA) records throughout your operation.
* Full investigations and data pertaining to any failing cephalosporin samples that were discarded since August 2024, including but not limited to sampling location, date, recovery amount, and any extra testing that was to be performed.
2. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). Your firm also failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)).
You operate (b)(4) processing lines used to aseptically manufacture sterile injectable drug products for the U.S. market. Your (b)(4) were inadequately validated to ensure that they were capable of consistently (b)(4) interior surfaces of your (b)(4) lines in preparation for aseptic production. In addition, your aseptic process simulations did not sufficiently represent worst-case conditions, and you lacked adequate sampling of your ISO 5 (Grade A) area.
Biological Indicator Recoveries and Inadequate (b)(4) Validation
Inadequacies in your (b)(4) process were demonstrated through a trend of routine recoveries of biological indicator (BI) growth at the completion of (b)(4) cycle re-qualification (validation) runs since (b)(4).
Notably, your acceptance criteria were inappropriate in that they allowed routine recovery of multiple BI survivors per re-qualification run. An adverse trend of numerous positive BIs were identified in multiple re-qualification cycles across multiple (b)(4) lines. For example, for line (b)(4), positive BIs occurred at numerous locations ((b)(4) of (b)(4) locations) and the positive findings included multiple replicates per location ((b)(4) recoveries of (b)(4) replicates). In addition, other lines had similar substantial findings of positive BIs. However, you considered all re-qualification studies to be acceptable and did not further evaluate the excessive variability of your (b)(4), including the potential impact to product. These significant recurring BI failures indicate poor (b)(4) method efficacy and require further investigation.
We also noted additional deficiencies in your (b)(4) reliability. For example:
* You lacked adequate scientific justification for BI locations.
* You allowed repetition of re-qualification cycles without proper investigation into observed BI growth.
* You did not align with technical references you cited in your procedures.
We note that you recovered (b)(4), from an (b)(4) inside your (b)(4) during production.
In your response, you commit to engaging a (b)(4) to help improve (b)(4), revising acceptance criteria to align with industry standards, and initiating non-conformance reports to investigate the observed BI growth. You also commit to evaluating alternative (b)(4) technology.
Your response is inadequate in that it does not provide sufficient detail or supporting documentation to describe how adequate (b)(4) will be achieved during the interim period prior to completion of long-term remediation.
Incomplete exposure of interior surfaces to (b)(4) compromises (b)(4) effectiveness and places your (b)(4) environment at risk. The (b)(4) (Grade A) area is critical because sterile products are exposed during aseptic production and therefore vulnerable to contamination if operations are not well designed and diligently controlled. Aseptic processing operations should be designed and executed to minimize exposure of sterile articles to potential contamination hazards in the manufacturing operation. Flaws in the design or control of cleanrooms and aseptic processing operations can enable entry of contaminants into the critical (b)(4) processing area and lead to product contamination.
Inadequate Aseptic Process Simulation
The intervention of (b)(4) was simulated approximately (b)(4) times during a media fill, but production records indicate a significantly higher occurrence of this intervention.
In your response you commit to updating the minimum number of (b)(4) simulations to (b)(4) based on your 2026 retrospective review, which only covered approximately (b)(4). Your response is inadequate as it does not ensure worst-case production activities and conditions are challenged across all (b)(4) lines. If a media fill program fails to incorporate contamination risk factors and closely simulate actual drug production, the state of process control and assurance of sterility cannot be accurately assessed.
Inadequate Environmental Monitoring
Your (b)(4) processing lines include critical operational steps conducted in (b)(4). However, there was only a (b)(4) in one of these (b)(4). In addition, surfaces were not monitored for microbiological contamination.
Vigilant and responsive environmental monitoring programs provide meaningful information on the state of control of the aseptic processing operation and enable an early warning system that identifies emerging contamination hazards before sterility is compromised.
Inadequate Airflow
Although your (b)(4) configurations can vary (e.g., (b)(4) bag capacity, (b)(4) configuration), you lacked airflow visualization studies in (b)(4) of your (b)(4) lines. In addition, your airflow visualization studies were insufficient (e.g., worst-case (b)(4) conditions).
We note that you have had a history of sporadic sterility test positives since 2013 (testing is routinely performed in a (b)(4)) and persistent particulate contamination issues.
Your airflow visualization studies also revealed substantial turbulence in your (b)(4), in which critical process steps are performed. Your firm acknowledged turbulent non-unidirectional airflow within your (b)(4), which houses processing equipment.
Our overall findings indicate significant deficiencies in the design of your aseptic processing operation. Your current equipment, process, and airflow design pose excessive contamination risk.
Turbulent airflow may be appropriate for a (b)(4) that does not house aseptic processing equipment. In contrast, your firm uses (b)(4) that include processing line equipment.
A strong quality system is essential to oversee design and construction of aseptic processing lines, cleanrooms, and supporting utilities, and to ensure ongoing proper operational control to safeguard against contamination hazards throughout the facility lifecycle.
Well-designed aseptic processing (b)(4) represent a significant technological advance over traditional operational designs. Because all technologies have failure modes, it is essential to implement a robust design and control program that enables an ongoing state of control.
See FDA's guidance document Sterile Drug Products Produced by Aseptic Processing--Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing at https://www.fda.gov/media/71026/download.
In your response, you commit to improving your EM program and performing airflow visualization studies on all of your lines. You also state that you will use data from these studies to identify locations for BIs and EM.
Your response is inadequate as you lack a commitment to upgrade your manufacturing infrastructure, including equipment replacement, as part of your long-term remediation plan. In addition, the timeline for implementation of additional viable air monitoring in the (b)(4) is unclear.
In response to this letter, provide:
* A detailed program for designing, validating, maintaining, controlling and monitoring each of your (b)(4) that includes vigilant monitoring to ensure an ongoing state of control.
* A comprehensive, independent risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, including but not limited to, the following:
- All human interactions within the (b)(4) area (e.g., risk reduction or elimination of manual interventions wherever possible)
- Equipment suitability (e.g., reliability, capability, ergonomics, placement) and sufficiency of space for operations
- Air quality in the (b)(4) area including, but not limited to, air unidirectionality
- Facility layout
- Personnel flow and material flow (movement throughout all rooms used to conduct and support sterile operations, and all material transfers)
- (b)(4) practices and procedures (e.g., (b)(4) efficacy, appropriate (b)(4) and configuration)
- Specific CAPA recommendations that will comprehensively address the design and control hazards identified in the risk assessment
* A detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe comprehensive improvements to be made to aseptic processing operation design and control at your facility and explain how this CAPA plan will systematically remediate your deficient sterile manufacturing operations. Include detailed changes to the design of both your aseptic processing lines and cleanrooms. Your action plan should include both an interim plan as well as long-term steps to fully remediate your facility, equipment, and process design.
* An independent review, detailed report, CAPA, and timelines for remediation of your (b)(4) methods (e.g., (b)(4) parameters, optimized airflow, improved surface exposure). This comprehensive, independent analysis should incorporate any differences between the design and operation of each (b)(4) and its processing equipment (e.g., dimensions, orientation, (b)(4) design, air volume, (b)(4), (b)(4) bowls, bag capacity, etc.).
* An independent, comprehensive evaluation of airflow unidirectionality in your aseptic processing operations. Ensure smoke studies are conducted under dynamic conditions with thorough and complete assessments of aseptic processing line airflow unidirectionality, including the impact of aseptic interventions, worst-case (b)(4) pattern, and dynamic interactions with the surrounding cleanroom. Conduct these smoke studies after you remediate your aseptic operation and using proper practices (e.g., (b)(4) media) to appropriately visualize airflow.
* A comprehensive, independent review of your process simulation (e.g., media fill) program to ensure accurate simulations of commercial aseptic manufacturing operations, including, but not limited to, appropriate incorporation of worst-case conditions.
* A summary table of all EM (includes surfaces, air, and (b)(4)) results within your (b)(4) lines that revealed microbial growth since January 1, 2023. Include line sample location, date, colony forming unit (CFU) count, microorganism identification, and any associated investigations.
3. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
Your manual visual inspection program was inadequate to reliably detect defects and ensure your sterile injectable drug products were essentially free of visible particulates.
For example, operators performing (b)(4) visual inspection were not properly qualified, as evidenced by the following:
* Operators were not appropriately challenged to ensure they were capable of reliably detecting particulates within the lower end of the visible spectrum.
* Particulates in challenge kits were excessively large (e.g., greater than (b)(4) microns), approximately (b)(4) times larger than what operators should be capable of reliably detecting.
* Operators' rate of inspection was excessively fast (e.g., (b)(4) per unit) and did not align with the standards referenced in your procedures.
* Notably, you also demonstrated poor detection rates when you used significantly longer inspection times during Acceptable Quality Limit (AQL) sampling.
Your approach to identifying product defects compromises reliable detection and the quality of data inputs to support batch release and CAPA decisions made by your quality unit.
In addition, the significant particulate matter complaints received between 2023 to 2025 indicate an inadequate visual inspection program. For example, on May 9, 2025, after testing a returned cefazolin complainant sample you confirmed foreign particulate contamination was consistent with cardboard (approximately (b)(4) mm). Your investigation concluded that inadequacies of visual inspection were a contributing cause, but you did not implement sufficient CAPA to ensure remediation of your visual inspection program.
Your investigation specifically cited potential for compromised product quality and potential patient safety risks, but stated that field action was not warranted. We acknowledge that on July 17, 2026, you agreed to voluntarily recall cefazolin, Lot LD175708, only after the Agency contacted you.
In your response you commit to enhancing your visual inspection program including performing probability of detection (PoD) studies using the (b)(4) per unit inspection duration.
Your response is inadequate. You indicate that data from post-market complaint evaluations and retain sample reviews confirm that your controls remain effective. However, you have identified particulate matter in retain and complaint samples after product was released. In addition, your response does not adequately address the spike in particulate matter defects from 2024 ((b)(4) defects) to 2025 ((b)(4) defects). There remains a lack of assurance that your injectable drug products are essentially free from visible particulates while you work on long-term remediation.
Visual detection of particulates is a probabilistic process that depends on, among other things, ensuring that visible particulates can be reproducibly detected by trained personnel with appropriate visual acuity. At a minimum, personnel should reliably be capable of detecting particulates of (b)(4) microns or greater at a (b)(4)% probability of detection. It is important that any visible particulate contamination is appropriately evaluated and investigated. Particulates in injectable products should be avoided through appropriate preventive measures built into your design and production controls. When categorizing any visible particles, extrinsic or foreign matter should receive special attention, as it may indicate possible microbial contamination. Extrinsic or foreign particulate contamination should occur very infrequently and trigger a thorough investigation and appropriate CAPA.
In response to this letter, provide:
* A comprehensive, independent assessment and remediation plan of your systems for the visual inspection of sterile injectable drugs for defects, including the presence of particulate matter. The assessment should include acceptance and rejection criteria, personnel training, supervision, equipment and personnel qualification, equipment maintenance, and process validation, and the procedures governing them. Also include product-specific knowledge, process experience (e.g., thorough assessment of the spike of (b)(4) particulate matter defects in 2025), deviation investigation analysis, and recall/complaint data. Provide your detailed remediation action plan that includes dates by which each remediation activity will be completed and a periodic independent reassessment of the plan's effectiveness. Include a summary of the review and recommendations made by your independent consultant.
* A comprehensive, independent assessment of each lot of sterile injectable drugs distributed from your facility that remains within expiry to meet the requirement of being essentially free of visible particles. This comprehensive review should include a review of all relevant in-process and finished product data obtained by your firm including all batch records.
* An interim plan for risk mitigation while you perform broader studies to improve your visual inspection program. Provide a detailed list of your risk mitigations (e.g., sampling plans and methods for your proposed destructive testing).
4. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
There was a pattern of inadequate investigations into critical issues, including leaking drug products and sterility failures.
Leaking Units
Your investigations into the "systemic nature" of container-closure integrity failures lacked effective CAPA to address the significantly increased rate of leak defects in your injectable drug products. You did not implement sufficient CAPA to ensure remediation of your final inspection program. Further, since 2023, media fill units were found leaking during incubation and you have received numerous leak complaints for marketed products.
All sterile drugs must be packaged using container-closure systems with robust protection that prevents the ingress of microorganisms. A product's ability to maintain integrity throughout anticipated stresses and external factors during manufacture, storage, distribution, and consumer use is critical to ensure product quality and safety. Loss of container-closure integrity is a direct cause of non-sterility.
In your response, you acknowledge that strengthening your investigation system is warranted and you will evaluate whether (b)(4) container closure integrity testing (CCIT) could be an effective layered control. You also commit to a retrospective review of critical non-conformance reports (NCR) and laboratory investigations for the last year.
Your response is inadequate. Limiting a retrospective review to (b)(4) lacks adequate scientific justification as your leak trending data illustrated the leak rate has consistently increased annually from 2023 to 2026. You also do not sufficiently address how a lack of highly capable leak detection systems impacts already produced products, or sufficiently detail improvements to your CAPA system. In addition, data from your firm indicates that although leak rate has increased, the number of NCRs opened has decreased.
Sterility Failure
Your investigation into a 2025 sterility failure for cefazolin, lot (b)(4), assigned the root cause as a non-integral test container. Test records had been signed and dated indicating that container integrity was initially verified. However, after observing turbidity, you subsequently stated in your investigation that container integrity was not verified, classifying it as a "no-test." Without conducting a Phase II investigation, you concluded there was no risk to the manufacturing process or finished product. You invalidated the sterility result without adequate scientific justification and released this lot in July 2025.
Notably, the same container integrity problem had been observed in the sterility test of (b)(4), lot (b)(4), in (b)(4), which you rejected.
In addition, a "no-test" designation was used for an (b)(4) cycle requalification attempt that resulted in numerous positive BIs.
In your response, you state your belief that the laboratory error of incubating non-integral sterility test containers was the definitive root cause. Your response is inadequate as it fails to address why your lab records described the test container as integral. It also fails to thoroughly address the lack of contemporaneous documentation of any subsequent deviation that could have theoretically occurred. You also commit to implementing a closed membrane sterility testing system in the future, but your proposal does not ensure timely remediation.
Product contamination may go undetected for substantial periods if your firm employs unreliable sterility testing practices. It should also be noted that any positive sterility test result represents a serious CGMP issue that requires a comprehensive investigation into the cause and extent of the problem, and a prompt review of the qualification status of the aseptic process.
Your firm's quality systems are inadequate. For guidance on establishing and maintaining CGMP-compliant quality systems, see FDA guidance documents: Q8(R2) Pharmaceutical Development at https://www.fda.gov/media/71535/download, Q9(R1) Quality Risk Management at https://www.fda.gov/media/167721/download, and Q10 Pharmaceutical Quality System at https://www.fda.gov/media/71553/download.
In response to this letter, provide:
* A comprehensive assessment and remediation plan to ensure your QU is given the authority, independence, and resources to effectively function. The assessment should also include, but not be limited to, the following:
- A determination of whether procedures used by your firm are robust and appropriate
- Provisions for independent QU oversight throughout your CGMP operations to ensure satisfactory procedures and adherence to appropriate practices
- A complete and final review of each batch and its related information before the QU disposition decision, including all investigations
- Oversight and approval of discharging of all QU duties to ensure identity, strength, quality, and purity of all products
- Also, describe how executive management supports robust quality assurance at your firm, including, but not limited to, timely provision of resources that enable proactive detection and resolution of emerging manufacturing/quality issues to assure a continuing state of control
* A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification results, out-of-limit results, and failures. Provide a detailed action plan to remediate this system, encompassing the following:
- Staff competencies (including use of appropriate subject matter experts)
- Written procedures
- Scientific rigor and foundation
- Scope determination
- Root cause evaluations
- CAPA effectiveness
- Quality unit lead functional roles, and oversight to ensure all phases of investigations are appropriately conducted
- And, based on above, detailed systemic improvements to the investigation system
* An independent third-party assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigation trends, improves the CAPA program when needed, implements final quality unit decisions, and is fully supported by executive management.
* Provide a comprehensive, independent process capability assessment of your aseptic processing lines, with special emphasis on the capability of critical operational steps, including but not limited to, all container-closure integrity failure modes, and any related CAPA to be initiated in response to the capability assessment.
* Perform a holistic assessment across your facilities for similar issues noted at this site and implement appropriate CAPA across your corporate network.
CGMP Consultant
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit1 of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm's compliance status with FDA.
Your use of a consultant does not relieve your firm's obligation to comply with CGMP.
Repeat Observations at Multiple Sites
In a previous regulatory meeting held on January 15, 2025, FDA discussed similar CGMP violations at this facility. You proposed specific remediations for these violations in your response.
FDA also cited similar CGMP violations at other facilities in your company's network. These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate.
Your firm's executive management remains responsible for fully resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance. You should immediately and comprehensively assess your company's global manufacturing operations to ensure that systems, processes, and the products manufactured conform to FDA requirements.
Drug Recall
On July 17, 2026, FDA held a teleconference with your firm and recommended that you voluntarily recall one lot of cefazolin and various (b)(4) drugs currently in distribution from the U.S. market, to which you agreed.
The company announcement for the cardboard particulate recall was posted to the FDA website: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-voluntary-nationwide-recall-cefazolin-dextrose-injection-usp-2g-100ml-20mg-ml-single
Request for a Meeting with FDA
After you submit your response to this warning letter, we recommend that you reach out to this office to arrange for a teleconference to discuss your corrective actions and preventive actions in detail. Direct your request to Kathryn Hall at CDER-OC-OMQ-Communications@fda.hhs.gov.
Conclusion
You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.
Unresolved violations may prevent other Federal agencies from awarding contracts. Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.
If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER's Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356c(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.
Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of receipt of this letter2. Identify your written response with FEI 1416980 and ATTN: Compliance Officer Matthew Schnupp in the letter or in the subject line of the email.
If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.
FDA posts warning letters to www.FDA.gov.
Sincerely,
/S/ Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
cc:
Ivan Quadrio
Site Director and Associate Vice President of Engineering
Baxter Healthcare Corporation
25212 W Il Route 120
Round Lake, IL 60073
Ivan_quadrio@baxter.com
Scott Kaplan
Head of Quality, Regulatory Affairs, and Patient Safety
Baxter Healthcare Corporation
1 Baxter Parkway
Deerfield, IL 60015
scott_kaplan@baxter.com
* * *
Footnotes:
1/ i.e., Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA's guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.
2/ Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/baxter-international-inc-733231-09292026
FCC Public Safety & Homeland Security Bureau Issues Public Notice: Conditional Approval, Exemption of Certain Routers, Advanced Robotic Devices From FCC Covered List
WASHINGTON, Oct. 22 (TNSdock) -- The Federal Communications Commission Public Safety and Homeland Security Bureau issued the following public notice (WC Docket No. 18-89; ET Docket No. 21-232; EA Docket No. 21-233):
* * *
The Federal Communications Commission's (FCC or Commission) Public Safety and Homeland Security Bureau (PSHSB or Bureau) maintains a list of equipment and services (Covered List) that have been determined to "pose an unacceptable risk to the national security of the United States or the security and safety of United States persons."/1 Pursuant to Section 2 of the Secure and ... Show Full Article WASHINGTON, Oct. 22 (TNSdock) -- The Federal Communications Commission Public Safety and Homeland Security Bureau issued the following public notice (WC Docket No. 18-89; ET Docket No. 21-232; EA Docket No. 21-233): * * * The Federal Communications Commission's (FCC or Commission) Public Safety and Homeland Security Bureau (PSHSB or Bureau) maintains a list of equipment and services (Covered List) that have been determined to "pose an unacceptable risk to the national security of the United States or the security and safety of United States persons."/1 Pursuant to Section 2 of the Secure andTrusted Communications Networks Act of 2019 (Secure Networks Act)/2 and sections 1.50002(a) and 1.50003 of the Commission's rules,/3 PSHSB announces that the Department of War (DoW) has granted Conditional Approval for certain foreign-produced routers and advanced robotic devices. Therefore, such devices are exempt from the Covered List.
Addition of Routers and Advanced Robotic Devices to the Covered List
Routers. On March 23, 2026, the Commission added to the Covered List "routers produced in a foreign country, except routers which have been granted a Conditional Approval by DoW or DHS."/4 This addition was based on a National Security Determination from an Executive Branch interagency body, including several appropriate national security agencies, determining (among other things) that routers produced in a foreign country pose an unacceptable risk to the national security of the United States and to the safety and security of U.S. persons./5
Advanced Robotic Devices. On July 28, 2026, the Commission added to the Covered List "foreign-produced advanced robotic devices, except advanced robotic devices which have been granted a Conditional Approval by DoW."/6 This addition was based on a National Security Determination from an Executive Branch interagency body, including several appropriate national security agencies, determining (among other things) that advanced robotic devices produced in a foreign country pose an unacceptable risk to the national security of the United States and to the safety and security of U.S. persons./7
Conditional Approvals
The Executive Branch interagency body established a process by which entities producing certain covered equipment in foreign countries can request DoW to evaluate whether such devices do not pose unacceptable risks to national security and receive Conditional Approvals that would exempt such devices from the Covered List. The Commission has previously updated the Covered List to reflect the Conditional Approvals that we have received from DoW exempting certain routers and advanced robotic devices from the Covered List./8
The Commission received National Security Determinations from DoW granting Conditional Approvals for the following devices:
* Micro-Star International Co., Ltd.'s Radix series GRBE94 and GRBE36 routers
* Vulcan Robotics Inc.'s Sourccey mobile robotic platform
Consistent with the National Security Determinations, these exemptions from the FCC's Covered List are subject to the companies' continuing "compliance with the onshoring plan[s] outlined in [their] conditional approval application[s]" and "pursuant to updated vetting of [their] products."/9
The Covered List
We find that the Conditional Approval constitutes "a specific determination" by DoW that such devices do not pose risks to U.S. national security./10 Therefore, we conclude that PSHSB is required to update the Covered List to exclude the equipment identified in the Conditional Approval.
PSHSB takes this action under its authority and obligation to publish and maintain the Covered List. Sections 1.50002(a) and 1.50003 of the Commission's rules require PSHSB to publish the Covered List on the Commission's website, to maintain and update the Covered List, and to monitor the status of determinations./11
The Covered List and the list of devices that have received Conditional Approvals are attached as Appendices A and B to this Public Notice and can also be found on the Bureau's website at https://www.fcc.gov/supplychain/coveredlist./12
We note the continued availability of FCC staff guidance pursuant to sections 0.191 and 0.31(i) of the Commission's rules. Commission staff will provide guidance to TCBs, test labs, and equipment authorization applicants on the impact of these updates.
For further information, please contact Matthew Chai, Attorney Advisor, Operations and Emergency Management Division, Public Safety and Homeland Security Bureau at 202-418-1112 or Matthew.Chai@fcc.gov.
* * *
Footnotes:
1/ Secure and Trusted Communications Networks Act of 2019, Pub. L. No. 116-124, 133 Stat. 158 (2020) (codified as amended at 47 U.S.C. Sec.Sec. 1601-1609) (Secure Networks Act); 47 CFR Sec.Sec. 1.50002, 1.50003. For the current version of the Covered List, see Federal Communications Commission, List of Equipment and Services Covered By Section 2 of The Secure Networks Act, https://www.fcc.gov/supplychain/coveredlist (last updated Oct. 21, 2026).
2/ 47 U.S.C. Sec. 1601.
3/ 47 CFR Sec.Sec. 1.50002(a), 1.50003; see also Protecting Against National Security Threats to the Communications Supply Chain Through FCC Programs, WC Docket No. 18-89, Second Report and Order, 35 FCC Rcd 14284 (2020) (Supply Chain Second Report and Order).
4/ FCC's Public Safety and Homeland Security Bureau Announces Addition of Routers Produced in Foreign Countries to FCC Covered List, WC Docket No. 18-89, Public Notice, DA 26-278 (Mar. 23, 2026) (Routers Public Notice).
5/ Routers Public Notice at 2.
6/ FCC's Public Safety and Homeland Security Bureau Announces Addition of Foreign-Produced Power Inverters and Advanced Robotic Devices to FCC Covered List, WC Docket No. 18-89, Public Notice, DA 26-786 (July 28, 2026) (Robotics Public Notice).
7/ Robotics Public Notice at 2.
8/ See, e.g., FCC's Public Safety and Homeland Security Bureau Announces Conditional Approval of Certain Routers and Uncrewed Aircraft Systems (UAS) and Exemption from FCC Covered List, WC Docket No. 18-89, Public Notice, DA-26-351 (April 14, 2026); FCC's Public Safety and Homeland Security Bureau Announces Conditional Approval and Exemption of Certain Advanced Robotic Devices from FCC Covered List, WC Docket No. 18-89, Public Notice, DA-26-996 (Sept. 18, 2026). The list of devices that have received Conditional Approvals can be found on the Bureau's website at https://www.fcc.gov/supplychain/coveredlist.
9/ Additionally, the National Security Determination states that failure to comply with the onshoring plan or the discovery of a false statement or misrepresentation in the Conditional Approval application could result in termination of the Conditional Approval and return of the equipment to the FCC's Covered List. Further, consistent with the National Security Determinations, Conditional Approvals related to advanced robotic devices that do not reflect termination dates will remain effective indefinitely, so long as the entity that received Conditional Approval abides by the onshoring plan outlined in its Conditional Approval application and pursuant to updated vetting of the products.
10/ See Routers Public Notice, Appx. C; Robotics Public Notice. Appx. C.
11/ 47 CFR Sec.Sec. 1.50002(a), 1.50003. See Supply Chain Second Report and Order, 35 FCC Rcd at 14319, 14325, paras. 72, 77, 92.
12/ The FCC website also contains a list of certain affiliates and subsidiaries of entities identified on the Covered List. The list of affiliates and subsidiaries does not constitute a comprehensive list of all entities that the Commission may find, upon further examination, to qualify as relevant subsidiaries or affiliates of entities on the Covered List. Those entities, whether or not they currently provide covered communications equipment or services, are subject to the Commission's prohibitions, such as the prohibition against obtaining authorizations for covered equipment. See Reminder: Communications Equipment and Services on the Covered List Pose an Unacceptable Risk to National Security, National Security Advisory No. 2025-01, DA 25-927, n.3 (PSHSB Oct. 14, 2025).
* * *
Original text plus appendix here: https://docs.fcc.gov/public/attachments/DA-26-1130A1.pdf
* * *
The Federal Communications Commission's (FCC or Commission) Public Safety and Homeland Security Bureau (PSHSB or Bureau) maintains a list of equipment and services (Covered List) that have been determined to "pose an unacceptable risk to the national security of the United States or the security and safety of United States persons."/1 Pursuant to Section 2 of the Secure and ... Show Full Article WASHINGTON, Oct. 22 (TNSdock) -- The Federal Communications Commission Public Safety and Homeland Security Bureau issued the following public notice (WC Docket No. 18-89; ET Docket No. 21-232; EA Docket No. 21-233): * * * The Federal Communications Commission's (FCC or Commission) Public Safety and Homeland Security Bureau (PSHSB or Bureau) maintains a list of equipment and services (Covered List) that have been determined to "pose an unacceptable risk to the national security of the United States or the security and safety of United States persons."/1 Pursuant to Section 2 of the Secure andTrusted Communications Networks Act of 2019 (Secure Networks Act)/2 and sections 1.50002(a) and 1.50003 of the Commission's rules,/3 PSHSB announces that the Department of War (DoW) has granted Conditional Approval for certain foreign-produced routers and advanced robotic devices. Therefore, such devices are exempt from the Covered List.
Addition of Routers and Advanced Robotic Devices to the Covered List
Routers. On March 23, 2026, the Commission added to the Covered List "routers produced in a foreign country, except routers which have been granted a Conditional Approval by DoW or DHS."/4 This addition was based on a National Security Determination from an Executive Branch interagency body, including several appropriate national security agencies, determining (among other things) that routers produced in a foreign country pose an unacceptable risk to the national security of the United States and to the safety and security of U.S. persons./5
Advanced Robotic Devices. On July 28, 2026, the Commission added to the Covered List "foreign-produced advanced robotic devices, except advanced robotic devices which have been granted a Conditional Approval by DoW."/6 This addition was based on a National Security Determination from an Executive Branch interagency body, including several appropriate national security agencies, determining (among other things) that advanced robotic devices produced in a foreign country pose an unacceptable risk to the national security of the United States and to the safety and security of U.S. persons./7
Conditional Approvals
The Executive Branch interagency body established a process by which entities producing certain covered equipment in foreign countries can request DoW to evaluate whether such devices do not pose unacceptable risks to national security and receive Conditional Approvals that would exempt such devices from the Covered List. The Commission has previously updated the Covered List to reflect the Conditional Approvals that we have received from DoW exempting certain routers and advanced robotic devices from the Covered List./8
The Commission received National Security Determinations from DoW granting Conditional Approvals for the following devices:
* Micro-Star International Co., Ltd.'s Radix series GRBE94 and GRBE36 routers
* Vulcan Robotics Inc.'s Sourccey mobile robotic platform
Consistent with the National Security Determinations, these exemptions from the FCC's Covered List are subject to the companies' continuing "compliance with the onshoring plan[s] outlined in [their] conditional approval application[s]" and "pursuant to updated vetting of [their] products."/9
The Covered List
We find that the Conditional Approval constitutes "a specific determination" by DoW that such devices do not pose risks to U.S. national security./10 Therefore, we conclude that PSHSB is required to update the Covered List to exclude the equipment identified in the Conditional Approval.
PSHSB takes this action under its authority and obligation to publish and maintain the Covered List. Sections 1.50002(a) and 1.50003 of the Commission's rules require PSHSB to publish the Covered List on the Commission's website, to maintain and update the Covered List, and to monitor the status of determinations./11
The Covered List and the list of devices that have received Conditional Approvals are attached as Appendices A and B to this Public Notice and can also be found on the Bureau's website at https://www.fcc.gov/supplychain/coveredlist./12
We note the continued availability of FCC staff guidance pursuant to sections 0.191 and 0.31(i) of the Commission's rules. Commission staff will provide guidance to TCBs, test labs, and equipment authorization applicants on the impact of these updates.
For further information, please contact Matthew Chai, Attorney Advisor, Operations and Emergency Management Division, Public Safety and Homeland Security Bureau at 202-418-1112 or Matthew.Chai@fcc.gov.
* * *
Footnotes:
1/ Secure and Trusted Communications Networks Act of 2019, Pub. L. No. 116-124, 133 Stat. 158 (2020) (codified as amended at 47 U.S.C. Sec.Sec. 1601-1609) (Secure Networks Act); 47 CFR Sec.Sec. 1.50002, 1.50003. For the current version of the Covered List, see Federal Communications Commission, List of Equipment and Services Covered By Section 2 of The Secure Networks Act, https://www.fcc.gov/supplychain/coveredlist (last updated Oct. 21, 2026).
2/ 47 U.S.C. Sec. 1601.
3/ 47 CFR Sec.Sec. 1.50002(a), 1.50003; see also Protecting Against National Security Threats to the Communications Supply Chain Through FCC Programs, WC Docket No. 18-89, Second Report and Order, 35 FCC Rcd 14284 (2020) (Supply Chain Second Report and Order).
4/ FCC's Public Safety and Homeland Security Bureau Announces Addition of Routers Produced in Foreign Countries to FCC Covered List, WC Docket No. 18-89, Public Notice, DA 26-278 (Mar. 23, 2026) (Routers Public Notice).
5/ Routers Public Notice at 2.
6/ FCC's Public Safety and Homeland Security Bureau Announces Addition of Foreign-Produced Power Inverters and Advanced Robotic Devices to FCC Covered List, WC Docket No. 18-89, Public Notice, DA 26-786 (July 28, 2026) (Robotics Public Notice).
7/ Robotics Public Notice at 2.
8/ See, e.g., FCC's Public Safety and Homeland Security Bureau Announces Conditional Approval of Certain Routers and Uncrewed Aircraft Systems (UAS) and Exemption from FCC Covered List, WC Docket No. 18-89, Public Notice, DA-26-351 (April 14, 2026); FCC's Public Safety and Homeland Security Bureau Announces Conditional Approval and Exemption of Certain Advanced Robotic Devices from FCC Covered List, WC Docket No. 18-89, Public Notice, DA-26-996 (Sept. 18, 2026). The list of devices that have received Conditional Approvals can be found on the Bureau's website at https://www.fcc.gov/supplychain/coveredlist.
9/ Additionally, the National Security Determination states that failure to comply with the onshoring plan or the discovery of a false statement or misrepresentation in the Conditional Approval application could result in termination of the Conditional Approval and return of the equipment to the FCC's Covered List. Further, consistent with the National Security Determinations, Conditional Approvals related to advanced robotic devices that do not reflect termination dates will remain effective indefinitely, so long as the entity that received Conditional Approval abides by the onshoring plan outlined in its Conditional Approval application and pursuant to updated vetting of the products.
10/ See Routers Public Notice, Appx. C; Robotics Public Notice. Appx. C.
11/ 47 CFR Sec.Sec. 1.50002(a), 1.50003. See Supply Chain Second Report and Order, 35 FCC Rcd at 14319, 14325, paras. 72, 77, 92.
12/ The FCC website also contains a list of certain affiliates and subsidiaries of entities identified on the Covered List. The list of affiliates and subsidiaries does not constitute a comprehensive list of all entities that the Commission may find, upon further examination, to qualify as relevant subsidiaries or affiliates of entities on the Covered List. Those entities, whether or not they currently provide covered communications equipment or services, are subject to the Commission's prohibitions, such as the prohibition against obtaining authorizations for covered equipment. See Reminder: Communications Equipment and Services on the Covered List Pose an Unacceptable Risk to National Security, National Security Advisory No. 2025-01, DA 25-927, n.3 (PSHSB Oct. 14, 2025).
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Original text plus appendix here: https://docs.fcc.gov/public/attachments/DA-26-1130A1.pdf