Federal Executive Branch
Here's a look at documents from the U.S. Executive Branch
Featured Stories
Treasury Successfully Implements New Safeguard to Stop Payments to Deceased Individuals
WASHINGTON, July 22 -- The U.S. Department of the Treasury issued the following news release:
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Treasury Successfully Implements New Safeguard to Stop Payments to Deceased Individuals
New Verification Process Screened Over 885 Million Federal Payments Worth Nearly $2.7 Trillion
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The U.S. Department of the Treasury and the Bureau of the Fiscal Service announced the successful implementation of a new government-wide payment verification process that helps stop federal payments from being sent to deceased individuals, fulfilling a key requirement of Executive Order 14249, Protecting America's ... Show Full Article WASHINGTON, July 22 -- The U.S. Department of the Treasury issued the following news release: * * * Treasury Successfully Implements New Safeguard to Stop Payments to Deceased Individuals New Verification Process Screened Over 885 Million Federal Payments Worth Nearly $2.7 Trillion - The U.S. Department of the Treasury and the Bureau of the Fiscal Service announced the successful implementation of a new government-wide payment verification process that helps stop federal payments from being sent to deceased individuals, fulfilling a key requirement of Executive Order 14249, Protecting America'sBank Account Against Fraud, Waste, and Abuse.
"Treasury has delivered on a key promise of President Trump's mandate to stop improper payments and fraud before money leaves the Treasury, and strengthen the integrity of the federal payment system," said Secretary Scott Bessent. "Together with Vice President Vance's Task Force to Eliminate Fraud, this new safeguard addresses a longstanding vulnerability and helps ensure every dollar the federal government spends reaches its intended recipient. Treasury will continue efforts to modernize the federal payment system, strengthen safeguards against fraud and improper payments, and protect taxpayer dollars."
BACKGROUND
Since President Trump issued Executive Order 14249, Protecting America's Bank Account Against Fraud, Waste, and Abuse, on March 25, 2025, Treasury has significantly expanded government-wide efforts to detect and prevent fraud and improper payments through the Do Not Pay program and new payment verification tools.
To date, Treasury has screened over 885 million payments totaling approximately $2.77 trillion as part of the new payment verification process. The screening has identified more than 4,900 payments worth approximately $99 million that were associated with deceased payees. Those payments were returned to the originating federal agencies for review before any funds were disbursed.
The new screening capability builds on Treasury's recent expanded access to the Social Security Administration's Full Death Master File, enabling more comprehensive identification of deceased payees before payments are issued. The Consolidated Appropriations Act of 2021 granted Treasury temporary access to the data for a three-year pilot program.
During the pilot's first year, Treasury significantly expanded its ability to identify deceased payees and projected an estimated $330 million in net benefits between 2024 and 2026 through reduced improper payments.
In February 2026, Congress passed, and President Trump signed, the Ending Improper Payments to Deceased People Act, providing Treasury with permanent access to the Full Death Master File and allowing these payment integrity efforts to continue on a permanent basis.
Treasury will continue implementing the payment verification capabilities required under the Executive Order to further strengthen safeguards against fraud, waste, and improper payments across the federal government.
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Original text here: https://home.treasury.gov/news/press-releases/sb0569
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Treasury Successfully Implements New Safeguard to Stop Payments to Deceased Individuals
New Verification Process Screened Over 885 Million Federal Payments Worth Nearly $2.7 Trillion
-
The U.S. Department of the Treasury and the Bureau of the Fiscal Service announced the successful implementation of a new government-wide payment verification process that helps stop federal payments from being sent to deceased individuals, fulfilling a key requirement of Executive Order 14249, Protecting America's ... Show Full Article WASHINGTON, July 22 -- The U.S. Department of the Treasury issued the following news release: * * * Treasury Successfully Implements New Safeguard to Stop Payments to Deceased Individuals New Verification Process Screened Over 885 Million Federal Payments Worth Nearly $2.7 Trillion - The U.S. Department of the Treasury and the Bureau of the Fiscal Service announced the successful implementation of a new government-wide payment verification process that helps stop federal payments from being sent to deceased individuals, fulfilling a key requirement of Executive Order 14249, Protecting America'sBank Account Against Fraud, Waste, and Abuse.
"Treasury has delivered on a key promise of President Trump's mandate to stop improper payments and fraud before money leaves the Treasury, and strengthen the integrity of the federal payment system," said Secretary Scott Bessent. "Together with Vice President Vance's Task Force to Eliminate Fraud, this new safeguard addresses a longstanding vulnerability and helps ensure every dollar the federal government spends reaches its intended recipient. Treasury will continue efforts to modernize the federal payment system, strengthen safeguards against fraud and improper payments, and protect taxpayer dollars."
BACKGROUND
Since President Trump issued Executive Order 14249, Protecting America's Bank Account Against Fraud, Waste, and Abuse, on March 25, 2025, Treasury has significantly expanded government-wide efforts to detect and prevent fraud and improper payments through the Do Not Pay program and new payment verification tools.
To date, Treasury has screened over 885 million payments totaling approximately $2.77 trillion as part of the new payment verification process. The screening has identified more than 4,900 payments worth approximately $99 million that were associated with deceased payees. Those payments were returned to the originating federal agencies for review before any funds were disbursed.
The new screening capability builds on Treasury's recent expanded access to the Social Security Administration's Full Death Master File, enabling more comprehensive identification of deceased payees before payments are issued. The Consolidated Appropriations Act of 2021 granted Treasury temporary access to the data for a three-year pilot program.
During the pilot's first year, Treasury significantly expanded its ability to identify deceased payees and projected an estimated $330 million in net benefits between 2024 and 2026 through reduced improper payments.
In February 2026, Congress passed, and President Trump signed, the Ending Improper Payments to Deceased People Act, providing Treasury with permanent access to the Full Death Master File and allowing these payment integrity efforts to continue on a permanent basis.
Treasury will continue implementing the payment verification capabilities required under the Executive Order to further strengthen safeguards against fraud, waste, and improper payments across the federal government.
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Original text here: https://home.treasury.gov/news/press-releases/sb0569
SEC Commissioner Uyeda Issues to Small Business Capital Formation Advisory Committee
WASHINGTON, July 22 -- The Securities and Exchange Commission issued the following remarks on July 21 2026, by Commissioner Mark T. Uyeda to the Small Business Capital Formation Advisory Committee:
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Good morning, and thank you all for being here.[1] Before turning to today's agenda, I want to welcome the five new members who joined this Committee last month: Anya Coverman, Joseph Lucosky, Andrew Prystai, Rodrigo Seira, and Erik Syvertsen. You bring perspectives from portfolio alternatives, capital markets law, early-stage venture, and fund formation. I look forward to your future contributions ... Show Full Article WASHINGTON, July 22 -- The Securities and Exchange Commission issued the following remarks on July 21 2026, by Commissioner Mark T. Uyeda to the Small Business Capital Formation Advisory Committee: * * * Good morning, and thank you all for being here.[1] Before turning to today's agenda, I want to welcome the five new members who joined this Committee last month: Anya Coverman, Joseph Lucosky, Andrew Prystai, Rodrigo Seira, and Erik Syvertsen. You bring perspectives from portfolio alternatives, capital markets law, early-stage venture, and fund formation. I look forward to your future contributionsand this Committee will be stronger for them.
At the last meeting in April, I raised several concerns about barriers for small companies accessing public markets: fixed compliance costs, underwriter economics that disfavored smaller companies, and a regulatory framework calibrated for large issuers.[2] Now I'd like us to spend less time on diagnosis and more time on potential solutions. Thus, I am pleased that the Committee will be briefed on the three proposals moving through the Commission right now: expanding Form S-3 eligibility and taking other steps to modernize the registered offering process, enhancing emerging growth company accommodations and simplifying filer status, and providing options for companies and their shareholders to determine their optimal periodic reporting cycles, whether that be semiannual or quarterly. Today you will hear directly from the Division of Corporation Finance on these three specific reforms.
Modernizing our rulebook is important. The Commission last took a hard look at improving the capital formation environment more than two decades ago. These proposals address concerns that our rules, forms, and guidance for public companies are outdated and disproportionately burdensome for smaller companies relative to benefits.
For example, consider Form S-3 and shelf registration. The framework we're currently operating under mostly dates to 2005--before the iPhone had even been rolled out.[3] It is also before the Commission required XBRL and structured data, which have created a very different disclosure environment. Expanding S-3 eligibility to more issuers, and streamlining the registration and communication rules that come with it, is an attempt to create a set of rules that more accurately reflects how information moves today. For a small company, that's not an abstract benefit--it's the difference between raising capital on a reasonable timeframe and watching a market window close during a lengthy registration process.
For each of these proposals, and any other potential regulatory reforms discussed today, the test I'd ask the Committee to apply is simple to state and hard to answer: is a given disclosure obligation producing information to investors that materially changes the enterprise value of a company or its stock price? Or is it a fixed cost that lands hardest on the companies with the fewest resources to absorb it?
This is a difficult question to answer in part because the costs we're talking about rarely show up as a single dramatic barrier. They accumulate--a threshold set too low, a deadline too tight, a filing requirement that made sense for a $10 billion company but gets applied to one a fraction of that size. Often a single line item does not look unreasonable in isolation. The cumulative effect is what pushes companies to stay private, or to leave the public markets. I hope that this Committee, comprised of individuals who are uniquely positioned to understand the barriers facing capital formation for small businesses, can tell us plainly if we've drawn the line in the wrong place. Or more importantly, how we should be thinking about applying principles-based rules rather than prescriptive mandates that attempt to create backdoor merit regulation.
Thank you again for your service, and I look forward to the discussion.
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[1] My remarks today reflect my views as an individual Commissioner and not necessarily the views of the full Commission or my fellow Commissioners.
[2] Commissioner Mark T. Uyeda, Remarks to the Small Business Capital Formation Advisory Committee (Apr. 28, 2026), available at https://www.sec.gov/newsroom/speeches-statements/uyeda-remarks-sbcfac-042826.
[3] Commissioner Mark T. Uyeda, Statement on Proposing Registered Offering Reform and Enhancement of Emerging Growth Company Accommodations and Simplification of Filer Status for Reporting Companies (May 19, 2026), available at https://www.sec.gov/newsroom/speeches-statements/uyeda-statement-proposing-registered-offering-reform-and-enhancement-of-emerging-growth-company-accommodations-and-simplification-of-filer-status-for-reporting-companies-051926#_ftn7.
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Original text here: https://www.sec.gov/newsroom/speeches-statements/uyeda-remarks-sbcfac-072126
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Good morning, and thank you all for being here.[1] Before turning to today's agenda, I want to welcome the five new members who joined this Committee last month: Anya Coverman, Joseph Lucosky, Andrew Prystai, Rodrigo Seira, and Erik Syvertsen. You bring perspectives from portfolio alternatives, capital markets law, early-stage venture, and fund formation. I look forward to your future contributions ... Show Full Article WASHINGTON, July 22 -- The Securities and Exchange Commission issued the following remarks on July 21 2026, by Commissioner Mark T. Uyeda to the Small Business Capital Formation Advisory Committee: * * * Good morning, and thank you all for being here.[1] Before turning to today's agenda, I want to welcome the five new members who joined this Committee last month: Anya Coverman, Joseph Lucosky, Andrew Prystai, Rodrigo Seira, and Erik Syvertsen. You bring perspectives from portfolio alternatives, capital markets law, early-stage venture, and fund formation. I look forward to your future contributionsand this Committee will be stronger for them.
At the last meeting in April, I raised several concerns about barriers for small companies accessing public markets: fixed compliance costs, underwriter economics that disfavored smaller companies, and a regulatory framework calibrated for large issuers.[2] Now I'd like us to spend less time on diagnosis and more time on potential solutions. Thus, I am pleased that the Committee will be briefed on the three proposals moving through the Commission right now: expanding Form S-3 eligibility and taking other steps to modernize the registered offering process, enhancing emerging growth company accommodations and simplifying filer status, and providing options for companies and their shareholders to determine their optimal periodic reporting cycles, whether that be semiannual or quarterly. Today you will hear directly from the Division of Corporation Finance on these three specific reforms.
Modernizing our rulebook is important. The Commission last took a hard look at improving the capital formation environment more than two decades ago. These proposals address concerns that our rules, forms, and guidance for public companies are outdated and disproportionately burdensome for smaller companies relative to benefits.
For example, consider Form S-3 and shelf registration. The framework we're currently operating under mostly dates to 2005--before the iPhone had even been rolled out.[3] It is also before the Commission required XBRL and structured data, which have created a very different disclosure environment. Expanding S-3 eligibility to more issuers, and streamlining the registration and communication rules that come with it, is an attempt to create a set of rules that more accurately reflects how information moves today. For a small company, that's not an abstract benefit--it's the difference between raising capital on a reasonable timeframe and watching a market window close during a lengthy registration process.
For each of these proposals, and any other potential regulatory reforms discussed today, the test I'd ask the Committee to apply is simple to state and hard to answer: is a given disclosure obligation producing information to investors that materially changes the enterprise value of a company or its stock price? Or is it a fixed cost that lands hardest on the companies with the fewest resources to absorb it?
This is a difficult question to answer in part because the costs we're talking about rarely show up as a single dramatic barrier. They accumulate--a threshold set too low, a deadline too tight, a filing requirement that made sense for a $10 billion company but gets applied to one a fraction of that size. Often a single line item does not look unreasonable in isolation. The cumulative effect is what pushes companies to stay private, or to leave the public markets. I hope that this Committee, comprised of individuals who are uniquely positioned to understand the barriers facing capital formation for small businesses, can tell us plainly if we've drawn the line in the wrong place. Or more importantly, how we should be thinking about applying principles-based rules rather than prescriptive mandates that attempt to create backdoor merit regulation.
Thank you again for your service, and I look forward to the discussion.
* * *
[1] My remarks today reflect my views as an individual Commissioner and not necessarily the views of the full Commission or my fellow Commissioners.
[2] Commissioner Mark T. Uyeda, Remarks to the Small Business Capital Formation Advisory Committee (Apr. 28, 2026), available at https://www.sec.gov/newsroom/speeches-statements/uyeda-remarks-sbcfac-042826.
[3] Commissioner Mark T. Uyeda, Statement on Proposing Registered Offering Reform and Enhancement of Emerging Growth Company Accommodations and Simplification of Filer Status for Reporting Companies (May 19, 2026), available at https://www.sec.gov/newsroom/speeches-statements/uyeda-statement-proposing-registered-offering-reform-and-enhancement-of-emerging-growth-company-accommodations-and-simplification-of-filer-status-for-reporting-companies-051926#_ftn7.
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Original text here: https://www.sec.gov/newsroom/speeches-statements/uyeda-remarks-sbcfac-072126
Relevance Through Medical Adaptation: AFMEDCOM Commander Visits AFSOC Mil-civ Partnership at UAB Hospital
HURLBURT FIELD, Florida, July 22 -- The U.S. Air Force Special Operations Command issued the following news:
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Relevance through medical adaptation: AFMEDCOM commander visits AFSOC mil-civ partnership at UAB Hospital
BIRMINGHAM, Ala. -- Special Operations Medicine is unlike any other medical field and requires lifesaving skills under immense pressure often in remote, austere and hostile environments. To ensure SOF medics are properly trained, Air Force Special Operations Command (AFSOC) fosters a Military-Civilian Partnership with the University of Alabama at Birmingham (UAB). This partnership ... Show Full Article HURLBURT FIELD, Florida, July 22 -- The U.S. Air Force Special Operations Command issued the following news: * * * Relevance through medical adaptation: AFMEDCOM commander visits AFSOC mil-civ partnership at UAB Hospital BIRMINGHAM, Ala. -- Special Operations Medicine is unlike any other medical field and requires lifesaving skills under immense pressure often in remote, austere and hostile environments. To ensure SOF medics are properly trained, Air Force Special Operations Command (AFSOC) fosters a Military-Civilian Partnership with the University of Alabama at Birmingham (UAB). This partnershipwas on full display during a visit by Lt. Gen. John J. DeGoes, U.S. Air Force Surgeon General and Air Force Medical Command commander, and Chief Master Sgt. James M. Woods, Chief of the Medical Enlisted Force and AFMEDCOM senior enlisted leader on June 17, 2026.
Established in 2006, the partnership between AFSOC and UAB Hospital has grown into a comprehensive medical training platform, preparing both officer and enlisted Special Operation Forces (SOF) medical professionals through clinical, rotational, embedded and research programs.
"This is a fantastic opportunity for our SOF medics to work side-by-side with civilian medical professionals in a high-volume Level 1 trauma center," said Col Brad Brough, AFSOC Command Surgeon. "The experiences gained here makes each SOF medic more proficient in complex interventions in order to support USSOCOM missions. The experience cannot be overstated."
Air Force Special Operations medics must meet U.S. Special Operations Command training and operational needs, which is why AFSOC and UAB Hospital have prioritized "relevance through adaptation," rapidly adapting programs to meet those evolving needs.
"We have had this partnership for two decades, offering military personnel the opportunity to grow their skill set in a civilian setting," said Dr. Jeff Kerby, director of the Trauma and Acute Surgery Division.
Following the tour of UAB Hospital, AFMEDCOM leadership visited Special Operations Center for Medical Integration and Development (SOCMID). SOCMID is an AFSOC medical training platform that provides advanced skill sustainment for enlisted medical professionals by blending military medical advances with cutting-edge civilian resuscitative care.
Pararescuemen, Special Operations Independent Duty Medical Technicians, and Joint service personnel all train at SOCMID which can see upwards of 300 personnel each year and hosts multiple courses annually. Among the courses include clinical rotations that ensure SOF medics in peacetime remain expertly proficient.
"This is a unique platform, one of the fifth largest hospitals in America, as far as volume and complexity, great academic medicine, great facilities that's continuing to grow. I see a lot of potential to bring some of our Air Force medics from multiple medical treatment facilities at Air Force bases that aren't getting to practice their full spectrum," said DeGoes.
UAB Hospital is home to central Alabama's only American College of Surgeons verified Level I Trauma Centers. This exposure to high-volume civilian trauma, emergency, and surgical units ensures when peacetime SOF medics deploy, their first time seeing a catastrophic injury in months is not on a remote battlefield.
"UAB's purpose is to be clinically excellent," said Dr. Daniel Cox, UAB trauma medical director and U.S. Air Force Reserve senior medical advisor. "These teams are who you need at a moment's notice and they can go and do whatever clinical job you need them to do in austere environments" Impressed by the training, DeGoes stressed the importance of intentionally resourcing, developing, and nurturing the AFSOC-UAB partnership.
"I'd like to invest a little more in the cadre that are here now, the staff that are working at UAB, and leading some of the training as student groups come in from AFSOC to prepare them optimally for whatever the special operations community needs," said DeGoes.
Remaining medically operationally ready any place, anytime, anywhere.
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Original text here: https://www.afsoc.af.mil/News/Article-Display/Article/4551660/relevance-through-medical-adaptation-afmedcom-commander-visits-afsoc-mil-civ-pa/
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Relevance through medical adaptation: AFMEDCOM commander visits AFSOC mil-civ partnership at UAB Hospital
BIRMINGHAM, Ala. -- Special Operations Medicine is unlike any other medical field and requires lifesaving skills under immense pressure often in remote, austere and hostile environments. To ensure SOF medics are properly trained, Air Force Special Operations Command (AFSOC) fosters a Military-Civilian Partnership with the University of Alabama at Birmingham (UAB). This partnership ... Show Full Article HURLBURT FIELD, Florida, July 22 -- The U.S. Air Force Special Operations Command issued the following news: * * * Relevance through medical adaptation: AFMEDCOM commander visits AFSOC mil-civ partnership at UAB Hospital BIRMINGHAM, Ala. -- Special Operations Medicine is unlike any other medical field and requires lifesaving skills under immense pressure often in remote, austere and hostile environments. To ensure SOF medics are properly trained, Air Force Special Operations Command (AFSOC) fosters a Military-Civilian Partnership with the University of Alabama at Birmingham (UAB). This partnershipwas on full display during a visit by Lt. Gen. John J. DeGoes, U.S. Air Force Surgeon General and Air Force Medical Command commander, and Chief Master Sgt. James M. Woods, Chief of the Medical Enlisted Force and AFMEDCOM senior enlisted leader on June 17, 2026.
Established in 2006, the partnership between AFSOC and UAB Hospital has grown into a comprehensive medical training platform, preparing both officer and enlisted Special Operation Forces (SOF) medical professionals through clinical, rotational, embedded and research programs.
"This is a fantastic opportunity for our SOF medics to work side-by-side with civilian medical professionals in a high-volume Level 1 trauma center," said Col Brad Brough, AFSOC Command Surgeon. "The experiences gained here makes each SOF medic more proficient in complex interventions in order to support USSOCOM missions. The experience cannot be overstated."
Air Force Special Operations medics must meet U.S. Special Operations Command training and operational needs, which is why AFSOC and UAB Hospital have prioritized "relevance through adaptation," rapidly adapting programs to meet those evolving needs.
"We have had this partnership for two decades, offering military personnel the opportunity to grow their skill set in a civilian setting," said Dr. Jeff Kerby, director of the Trauma and Acute Surgery Division.
Following the tour of UAB Hospital, AFMEDCOM leadership visited Special Operations Center for Medical Integration and Development (SOCMID). SOCMID is an AFSOC medical training platform that provides advanced skill sustainment for enlisted medical professionals by blending military medical advances with cutting-edge civilian resuscitative care.
Pararescuemen, Special Operations Independent Duty Medical Technicians, and Joint service personnel all train at SOCMID which can see upwards of 300 personnel each year and hosts multiple courses annually. Among the courses include clinical rotations that ensure SOF medics in peacetime remain expertly proficient.
"This is a unique platform, one of the fifth largest hospitals in America, as far as volume and complexity, great academic medicine, great facilities that's continuing to grow. I see a lot of potential to bring some of our Air Force medics from multiple medical treatment facilities at Air Force bases that aren't getting to practice their full spectrum," said DeGoes.
UAB Hospital is home to central Alabama's only American College of Surgeons verified Level I Trauma Centers. This exposure to high-volume civilian trauma, emergency, and surgical units ensures when peacetime SOF medics deploy, their first time seeing a catastrophic injury in months is not on a remote battlefield.
"UAB's purpose is to be clinically excellent," said Dr. Daniel Cox, UAB trauma medical director and U.S. Air Force Reserve senior medical advisor. "These teams are who you need at a moment's notice and they can go and do whatever clinical job you need them to do in austere environments" Impressed by the training, DeGoes stressed the importance of intentionally resourcing, developing, and nurturing the AFSOC-UAB partnership.
"I'd like to invest a little more in the cadre that are here now, the staff that are working at UAB, and leading some of the training as student groups come in from AFSOC to prepare them optimally for whatever the special operations community needs," said DeGoes.
Remaining medically operationally ready any place, anytime, anywhere.
* * *
Original text here: https://www.afsoc.af.mil/News/Article-Display/Article/4551660/relevance-through-medical-adaptation-afmedcom-commander-visits-afsoc-mil-civ-pa/
PT Organics Limited Recalls Select Pumpkin Tree Peter Rabbit Organics Banana & Strawberry Fruit Puree Pouches Due to the Potential for Soft Plastic to Enter the Finished Product
WASHINGTON, July 22 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following recall notice:
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PT Organics Limited Recalls Select Pumpkin Tree Peter Rabbit Organics Banana & Strawberry Fruit Puree Pouches Due to the Potential for Soft Plastic to Enter the Finished Product
Summary
Company Announcement Date: July 21, 2026
FDA Publish Date: July 21, 2026
Product Type: Food & Beverages
Reason for Announcement: Potential presence of soft plastic in the finished product.
Company Name: PT Organics Limited
Brand Name: Pumpkin Tree Peter Rabbit Organics
Product ... Show Full Article WASHINGTON, July 22 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following recall notice: * * * PT Organics Limited Recalls Select Pumpkin Tree Peter Rabbit Organics Banana & Strawberry Fruit Puree Pouches Due to the Potential for Soft Plastic to Enter the Finished Product Summary Company Announcement Date: July 21, 2026 FDA Publish Date: July 21, 2026 Product Type: Food & Beverages Reason for Announcement: Potential presence of soft plastic in the finished product. Company Name: PT Organics Limited Brand Name: Pumpkin Tree Peter Rabbit Organics ProductDescription: Banana & Strawberry Fruit Puree Pouches, 4 oz. (113 g)
Company Announcement
July 21st, 2026, PT Organics Limited of Lake Oswego, Oregon is voluntarily recalling select Pumpkin Tree Peter Rabbit Organics Banana & Strawberry 4 oz. (113 g) pouches because of an internal packaging defect that may result in the presence of a strand of soft, food-grade plastic in the finished product.
The recalled product was sold exclusively through Kroger, Meijer, and Target retail stores nationwide between 03/06/2026 and 07/13/2026.
The recalled Pumpkin Tree Peter Rabbit Organics Banana & Strawberry 4 oz. (113 g) pouches can be identified by the following codes, which are stamped in black ink on the back of the pouch:
* Barcode: 8 15367 01078 0
* Lane number - identified by the number '4' printed on the rear right-hand side seam
* Best-Before-Date (BBD) of 01/19/2027, 01/20/2027, 03/17/2027, 03/18/2027, 05/14/2027, or 05/15/2027.
No injuries have been reported. No other Pumpkin Tree branded products, best-before-dates, or flavors are affected by this recall.
PT Organics Limited initiated this voluntary recall after its packaging supplier last week recalled a production run of defective pouches. PT Organics' inspections of finished product made with the recalled packaging confirmed the presence of a strand of a soft, food-grade plastic attached to the inside of a small number of pouches.
What to do if you have one of these products
PT Organics Limited encourages consumers and caregivers to check their products against the barcode, lane number and best-before-dates listed above.
Consumers or caregivers who have recalled product in their possession should dispose of it or return the product to the place of purchase. It should not be eaten or fed to another person.
Consumers with questions or concerns may visit our website www.pumpkintreesnacks.comExternal Link Disclaimer or contact us via our consumer support desk at 888-566-2363, M-F, 8:00 am - 5:00 pm E.T. for more information.
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Original text here: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pt-organics-limited-recalls-select-pumpkin-tree-peter-rabbit-organics-banana-strawberry-fruit-puree
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PT Organics Limited Recalls Select Pumpkin Tree Peter Rabbit Organics Banana & Strawberry Fruit Puree Pouches Due to the Potential for Soft Plastic to Enter the Finished Product
Summary
Company Announcement Date: July 21, 2026
FDA Publish Date: July 21, 2026
Product Type: Food & Beverages
Reason for Announcement: Potential presence of soft plastic in the finished product.
Company Name: PT Organics Limited
Brand Name: Pumpkin Tree Peter Rabbit Organics
Product ... Show Full Article WASHINGTON, July 22 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following recall notice: * * * PT Organics Limited Recalls Select Pumpkin Tree Peter Rabbit Organics Banana & Strawberry Fruit Puree Pouches Due to the Potential for Soft Plastic to Enter the Finished Product Summary Company Announcement Date: July 21, 2026 FDA Publish Date: July 21, 2026 Product Type: Food & Beverages Reason for Announcement: Potential presence of soft plastic in the finished product. Company Name: PT Organics Limited Brand Name: Pumpkin Tree Peter Rabbit Organics ProductDescription: Banana & Strawberry Fruit Puree Pouches, 4 oz. (113 g)
Company Announcement
July 21st, 2026, PT Organics Limited of Lake Oswego, Oregon is voluntarily recalling select Pumpkin Tree Peter Rabbit Organics Banana & Strawberry 4 oz. (113 g) pouches because of an internal packaging defect that may result in the presence of a strand of soft, food-grade plastic in the finished product.
The recalled product was sold exclusively through Kroger, Meijer, and Target retail stores nationwide between 03/06/2026 and 07/13/2026.
The recalled Pumpkin Tree Peter Rabbit Organics Banana & Strawberry 4 oz. (113 g) pouches can be identified by the following codes, which are stamped in black ink on the back of the pouch:
* Barcode: 8 15367 01078 0
* Lane number - identified by the number '4' printed on the rear right-hand side seam
* Best-Before-Date (BBD) of 01/19/2027, 01/20/2027, 03/17/2027, 03/18/2027, 05/14/2027, or 05/15/2027.
No injuries have been reported. No other Pumpkin Tree branded products, best-before-dates, or flavors are affected by this recall.
PT Organics Limited initiated this voluntary recall after its packaging supplier last week recalled a production run of defective pouches. PT Organics' inspections of finished product made with the recalled packaging confirmed the presence of a strand of a soft, food-grade plastic attached to the inside of a small number of pouches.
What to do if you have one of these products
PT Organics Limited encourages consumers and caregivers to check their products against the barcode, lane number and best-before-dates listed above.
Consumers or caregivers who have recalled product in their possession should dispose of it or return the product to the place of purchase. It should not be eaten or fed to another person.
Consumers with questions or concerns may visit our website www.pumpkintreesnacks.comExternal Link Disclaimer or contact us via our consumer support desk at 888-566-2363, M-F, 8:00 am - 5:00 pm E.T. for more information.
* * *
Original text here: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pt-organics-limited-recalls-select-pumpkin-tree-peter-rabbit-organics-banana-strawberry-fruit-puree
FDA Center for Tobacco Products Issues Warning Letter to Indejuicevapestore.co.uk
WASHINGTON, July 22 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to indejuicevapestore.co.uk from its Center for Tobacco Products:
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Recipient: indejuicevapestore.co.uk, United States, info@indejuicevapestore.co.uk
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://indejuicevapestore.co.uk and determined that e-liquid products listed there are offered for ... Show Full Article WASHINGTON, July 22 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to indejuicevapestore.co.uk from its Center for Tobacco Products: * * * Recipient: indejuicevapestore.co.uk, United States, info@indejuicevapestore.co.uk 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://indejuicevapestore.co.uk and determined that e-liquid products listed there are offered forsale or 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 e-liquid 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 Just Juice 10ml Nic Salt - Apple & Pear on Ice e-liquid 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://indejuicevapestore.co.uk, a person younger than 21 years of age purchased Just Juice 10ml Nic Salt - Apple & Pear on Ice e-liquid 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, RW2602433, 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/ Ele Ibarra-Pratt, Acting Director, Office of Compliance and Enforcement, Center for Tobacco Products
VIA Electronic Mail
cc:
Namecheap, Inc.
abuse@namecheap.com
Vercel, Inc.
abuse@vercel.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/indejuicevapestorecouk-734052-07102026
* * *
Recipient: indejuicevapestore.co.uk, United States, info@indejuicevapestore.co.uk
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://indejuicevapestore.co.uk and determined that e-liquid products listed there are offered for ... Show Full Article WASHINGTON, July 22 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to indejuicevapestore.co.uk from its Center for Tobacco Products: * * * Recipient: indejuicevapestore.co.uk, United States, info@indejuicevapestore.co.uk 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://indejuicevapestore.co.uk and determined that e-liquid products listed there are offered forsale or 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 e-liquid 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 Just Juice 10ml Nic Salt - Apple & Pear on Ice e-liquid 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://indejuicevapestore.co.uk, a person younger than 21 years of age purchased Just Juice 10ml Nic Salt - Apple & Pear on Ice e-liquid 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, RW2602433, 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/ Ele Ibarra-Pratt, Acting Director, Office of Compliance and Enforcement, Center for Tobacco Products
VIA Electronic Mail
cc:
Namecheap, Inc.
abuse@namecheap.com
Vercel, Inc.
abuse@vercel.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/indejuicevapestorecouk-734052-07102026
FDA Center for Drug Evaluation & Research Issues Warning Letter to Almon Healthcare
WASHINGTON, July 22 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Almon Healthcare Private Limited from its Center for Drug Evaluation and Research:
* * *
Recipient: Mr. Rajesh Gandhi, Chairman, Almon Healthcare Private Limited, Plot No 4, Sankalp Industrial Estate, Behind Kerala GIDC, Bavala, Ahmedabad 382240 Gujarat, India
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
Warning Letter 320-26-102
Dear Mr. Gandhi:
The United States Food and Drug Administration (FDA) inspected your drug ... Show Full Article WASHINGTON, July 22 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Almon Healthcare Private Limited from its Center for Drug Evaluation and Research: * * * Recipient: Mr. Rajesh Gandhi, Chairman, Almon Healthcare Private Limited, Plot No 4, Sankalp Industrial Estate, Behind Kerala GIDC, Bavala, Ahmedabad 382240 Gujarat, India Issuing Office: Center for Drug Evaluation and Research (CDER), United States Warning Letter 320-26-102 Dear Mr. Gandhi: The United States Food and Drug Administration (FDA) inspected your drugmanufacturing facility, Almon Healthcare Private Limited, FEI 3030509366, at Plot No 4, Sankalp Industrial Estate, Behind Kerala GIDC, Bavala, Ahmedabad, from February 9 to 13, 2026.
This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs 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 March 6, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.
During our inspection, our investigator observed specific deviations including, but not limited to, the following.
1. Failure of your quality unit to exercise its responsibility to ensure the API and intermediates manufactured at your facility are in compliance with CGMP.
Your quality unit (QU) failed to perform identity testing on incoming raw materials used in the manufacture of APIs (b)(4), which are intended for use in pharmacy compounding.
Specifically, your firm intentionally accepted lots of (b)(4) that were deliberately mislabeled by your supplier as (b)(4). During the inspection, your QU admitted that this was a deliberate and ongoing practice since 2024 to circumvent your firm's lack of a required (b)(4) license. You subsequently used this mislabeled and untested material to manufacture multiple batches of (b)(4) that you ultimately shipped to the United States. Furthermore, your QU relied on your supplier's certificate of analysis without conducting supplier qualification as your standard operating procedure requires.
In your response, you acknowledge the mislabeling practice, state you have since obtained the required (b)(4) license, and commit to performing identity testing of all future lots of (b)(4). You also state that a retrospective reevaluation of residual solvent chromatographic data confirms that peaks previously observed in the affected (b)(4) batches are attributable to (b)(4).
Your response is inadequate. Your analytical conclusions are unsubstantiated because your response does not provide the supporting chromatograms or results from your identity tests. Furthermore, you do not provide a risk assessment for batches already distributed to the United States. Your response also does not address the systemic quality failure that allowed your firm to knowingly accept and recode mislabeled materials without performing identity testing. Finally, you fail to propose any substantive corrective actions to remediate your supplier qualification program to prevent a recurrence of this critical failure.
Without adequate testing, you do not have scientific evidence that incoming materials conform to appropriate specifications prior to use in the manufacture of your drugs. As a manufacturer, you have a responsibility to sample, test, and examine incoming materials before use in production to assure adequate quality. Executive management should immediately and comprehensively assess your company's global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.
Your practice of receiving (b)(4) mislabeled as (b)(4) poses a significant safety risk to personnel who may handle the material without knowing its true identity. Due to lack of awareness, workers may fail to take the precautions necessary to prevent exposure. (b)(4) is acutely toxic to humans and has caused fatal poisoning incidents worldwide.
Furthermore, an adequate QU overseeing all elements of CGMP is necessary to consistently ensure drug quality. FDA considers the expectations outlined in ICH Q7 when determining whether API are manufactured in conformance with CGMP, including the sections on quality oversight. See FDA's guidance document Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients for guidance regarding CGMP for the manufacture of API at https://www.fda.gov/media/71518/download.
In response to this letter, provide:
* A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
- A determination of whether procedures used by your firm are robust and appropriate
- Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
- A complete and final review of each batch and its related information before the QU disposition decision
- Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products
- Also describe how top management supports quality assurance and reliable operations including, but not limited to timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.
2. Failure to ensure that all test procedures are scientifically sound and appropriate to ensure that your intermediate and API conform to established standards of quality and purity.
Your firm failed to validate or adequately verify multiple test methods used for testing key starting materials and finished APIs. Specifically, you did not validate the in-house analytical methods, including the stability-indicating methods, used to support the (b)(4) retest dates for your products shipped to the United States. Furthermore, your firm failed to adequately implement and verify an analytical method transferred from your contract testing laboratory CTL) used for routine testing and stability studies of (b)(4). Your implemented method was unable to detect multiple unknown impurities that your CTL's validated method identified.
In your response, you commit to executing forced degradation studies to demonstrate your methods are stability-indicating and to reassessing the validity of the assigned (b)(4) retest dates for the APIs shipped to the United States. You also commit to executing validation and verification protocols for compendial and in-house methods. You attribute the discrepancy in impurity detection in (b)(4) to an incorrectly set processing threshold and provide reprocessed data to suggest your results are now comparable.
Your response is inadequate because it fails to comprehensively assess your laboratory systems to ensure that all test methods are appropriately validated or verified. You have not established any interim controls for ongoing production while you conduct your retrospective review of batches tested with unvalidated methods. Additionally, while you attempt to explain the threshold differences between the CTL and the in-house verification study for (b)(4), you fail to address whether the methods are truly equivalent.
Without an appropriate laboratory and stability-indicating methods, you lack adequate scientific evidence to support whether your drug products meet established specifications and retain their quality attributes through their labeled expiry.
In response to this letter, provide:
* A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
* A list of validated/verified chemical specifications, including test methods, used to analyze each batch of your drug products before a lot disposition decision.
- An action plan and timelines for conducting full chemical testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.
- A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.
* A comprehensive assessment and corrective action and preventive action plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:
- Stability-indicating methods
- Stability studies for each drug product in its marketed container-closure system before distribution is permitted
- An ongoing program in which representative batches of each product are added each year to the program to determine the shelf-life claim remains valid
- Detailed definition of the specific attributes to be tested at each station (timepoint)
- All procedures that describe these and other elements of your remediated stability program
* Confirm the retest dates for (b)(4) using the revalidated stability-indicating method. This reassessment should ensure that all previously assigned retest dates are accurate.
3. Failure to clean equipment to prevent contamination or carry-over of a material that would alter the quality of the intermediates and API beyond the official or other established specifications.
Your firm failed to adequately clean and maintain non-dedicated API manufacturing equipment used to manufacture as many as (b)(4) different APIs. For example, our investigator observed (b)(4) and (b)(4) particles on product contact surfaces, including the lid and (b)(4) of (b)(4), and (b)(4) liquid draining from the (b)(4) even though the (b)(4) was documented as "empty and cleaned." Additionally, your firm failed to maintain cleaning records for a non-dedicated (b)(4) product transfer pipe.
Your cleaning verification report for (b)(4) addressed only batch-to-batch cleaning. It did not address product changeover. It also lacked scientific justification for product selection and residue limit calculations based on solubility, difficulty of cleaning, and toxicity, as required by your cleaning validation procedure. Your firm affirmed to our investigator that no formal cleaning validation has been performed and that you have not established a maximum allowable carryover limit as required by your procedure.
In your response, you attribute the observed residues on the (b)(4) to the previous batch of the same non-U.S. API, explaining that only a "gross cleaning" is performed between batches during a (b)(4). You conclude there was no risk of carryover. You assert that the (b)(4) transfer pipe is dedicated to a (b)(4) and also conclude there is no cross-contamination risk and confirm you do not use cleaning logs.
Furthermore, you state that you "executed cleaning validation/verification activities for selected products" manufactured on shared equipment.
Your response is inadequate because it does not provide assurance that your cleaning processes are adequate to prevent cross-contamination and carryover risks. It addresses only the (b)(4) particles observed in the (b)(4), attributing them to a non-U.S. API campaign, while failing to test the observed (b)(4) liquid and other particle deposits. You did not expand your investigation to other equipment or conduct a retrospective review of released batches to assess product impact.
Your claim that the (b)(4) transfer pipe is dedicated to a (b)(4) is unsubstantiated and contradicts information provided during the inspection. Further, you do not explain why cleaning validation was limited to selected products, nor do you provide supporting documentation to support or demonstrate that your cleaning practices adequately remove product residues.
Inadequately cleaned and maintained manufacturing equipment can lead to potential cross-contamination that could compromise your API's quality and safety.
In response to this letter, provide:
* A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment of whether cross-contaminated products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices and encompass each piece of manufacturing equipment used to manufacture intermediates and API products.
* Appropriate improvements to your cleaning validation program with special emphasis on incorporating conditions identified as worst case in your API manufacturing operations. This should include but not be limited to identification and evaluation of all worst-case:
- Drugs with higher toxicities
- Drugs with higher potencies
- Drugs with lower solubility in their cleaning solvents
- Drugs with characteristics that make them difficult to clean
- Swabbing locations for areas that are most difficult to clean
- Maximum hold times before cleaning
* A summary of updated standard operating procedures that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.
CGMP Consultant Recommended
Based upon the nature of the deviations we identified at your firm, you should engage a consultant qualified to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit 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. Your firm's executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
Conclusion
The deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.
FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on June 9, 2026.
Correct any deviations promptly. FDA may withhold approval of new applications or supplements listing your firm as a manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations.
Failure to address any deviations may also result in the FDA continuing to refuse admission of articles manufactured at Almon Healthcare Private Limited located at Plot No 4, Sankalp Industrial Estate, Behind Kerala GIDC, Bavala, Ahmedabad, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3030509366 and ATTN: Jamie Dion.
Sincerely,
/S/ Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/almon-healthcare-private-limited-729291-07132026
* * *
Recipient: Mr. Rajesh Gandhi, Chairman, Almon Healthcare Private Limited, Plot No 4, Sankalp Industrial Estate, Behind Kerala GIDC, Bavala, Ahmedabad 382240 Gujarat, India
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
Warning Letter 320-26-102
Dear Mr. Gandhi:
The United States Food and Drug Administration (FDA) inspected your drug ... Show Full Article WASHINGTON, July 22 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Almon Healthcare Private Limited from its Center for Drug Evaluation and Research: * * * Recipient: Mr. Rajesh Gandhi, Chairman, Almon Healthcare Private Limited, Plot No 4, Sankalp Industrial Estate, Behind Kerala GIDC, Bavala, Ahmedabad 382240 Gujarat, India Issuing Office: Center for Drug Evaluation and Research (CDER), United States Warning Letter 320-26-102 Dear Mr. Gandhi: The United States Food and Drug Administration (FDA) inspected your drugmanufacturing facility, Almon Healthcare Private Limited, FEI 3030509366, at Plot No 4, Sankalp Industrial Estate, Behind Kerala GIDC, Bavala, Ahmedabad, from February 9 to 13, 2026.
This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs 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 March 6, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.
During our inspection, our investigator observed specific deviations including, but not limited to, the following.
1. Failure of your quality unit to exercise its responsibility to ensure the API and intermediates manufactured at your facility are in compliance with CGMP.
Your quality unit (QU) failed to perform identity testing on incoming raw materials used in the manufacture of APIs (b)(4), which are intended for use in pharmacy compounding.
Specifically, your firm intentionally accepted lots of (b)(4) that were deliberately mislabeled by your supplier as (b)(4). During the inspection, your QU admitted that this was a deliberate and ongoing practice since 2024 to circumvent your firm's lack of a required (b)(4) license. You subsequently used this mislabeled and untested material to manufacture multiple batches of (b)(4) that you ultimately shipped to the United States. Furthermore, your QU relied on your supplier's certificate of analysis without conducting supplier qualification as your standard operating procedure requires.
In your response, you acknowledge the mislabeling practice, state you have since obtained the required (b)(4) license, and commit to performing identity testing of all future lots of (b)(4). You also state that a retrospective reevaluation of residual solvent chromatographic data confirms that peaks previously observed in the affected (b)(4) batches are attributable to (b)(4).
Your response is inadequate. Your analytical conclusions are unsubstantiated because your response does not provide the supporting chromatograms or results from your identity tests. Furthermore, you do not provide a risk assessment for batches already distributed to the United States. Your response also does not address the systemic quality failure that allowed your firm to knowingly accept and recode mislabeled materials without performing identity testing. Finally, you fail to propose any substantive corrective actions to remediate your supplier qualification program to prevent a recurrence of this critical failure.
Without adequate testing, you do not have scientific evidence that incoming materials conform to appropriate specifications prior to use in the manufacture of your drugs. As a manufacturer, you have a responsibility to sample, test, and examine incoming materials before use in production to assure adequate quality. Executive management should immediately and comprehensively assess your company's global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.
Your practice of receiving (b)(4) mislabeled as (b)(4) poses a significant safety risk to personnel who may handle the material without knowing its true identity. Due to lack of awareness, workers may fail to take the precautions necessary to prevent exposure. (b)(4) is acutely toxic to humans and has caused fatal poisoning incidents worldwide.
Furthermore, an adequate QU overseeing all elements of CGMP is necessary to consistently ensure drug quality. FDA considers the expectations outlined in ICH Q7 when determining whether API are manufactured in conformance with CGMP, including the sections on quality oversight. See FDA's guidance document Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients for guidance regarding CGMP for the manufacture of API at https://www.fda.gov/media/71518/download.
In response to this letter, provide:
* A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
- A determination of whether procedures used by your firm are robust and appropriate
- Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
- A complete and final review of each batch and its related information before the QU disposition decision
- Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products
- Also describe how top management supports quality assurance and reliable operations including, but not limited to timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.
2. Failure to ensure that all test procedures are scientifically sound and appropriate to ensure that your intermediate and API conform to established standards of quality and purity.
Your firm failed to validate or adequately verify multiple test methods used for testing key starting materials and finished APIs. Specifically, you did not validate the in-house analytical methods, including the stability-indicating methods, used to support the (b)(4) retest dates for your products shipped to the United States. Furthermore, your firm failed to adequately implement and verify an analytical method transferred from your contract testing laboratory CTL) used for routine testing and stability studies of (b)(4). Your implemented method was unable to detect multiple unknown impurities that your CTL's validated method identified.
In your response, you commit to executing forced degradation studies to demonstrate your methods are stability-indicating and to reassessing the validity of the assigned (b)(4) retest dates for the APIs shipped to the United States. You also commit to executing validation and verification protocols for compendial and in-house methods. You attribute the discrepancy in impurity detection in (b)(4) to an incorrectly set processing threshold and provide reprocessed data to suggest your results are now comparable.
Your response is inadequate because it fails to comprehensively assess your laboratory systems to ensure that all test methods are appropriately validated or verified. You have not established any interim controls for ongoing production while you conduct your retrospective review of batches tested with unvalidated methods. Additionally, while you attempt to explain the threshold differences between the CTL and the in-house verification study for (b)(4), you fail to address whether the methods are truly equivalent.
Without an appropriate laboratory and stability-indicating methods, you lack adequate scientific evidence to support whether your drug products meet established specifications and retain their quality attributes through their labeled expiry.
In response to this letter, provide:
* A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
* A list of validated/verified chemical specifications, including test methods, used to analyze each batch of your drug products before a lot disposition decision.
- An action plan and timelines for conducting full chemical testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.
- A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.
* A comprehensive assessment and corrective action and preventive action plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:
- Stability-indicating methods
- Stability studies for each drug product in its marketed container-closure system before distribution is permitted
- An ongoing program in which representative batches of each product are added each year to the program to determine the shelf-life claim remains valid
- Detailed definition of the specific attributes to be tested at each station (timepoint)
- All procedures that describe these and other elements of your remediated stability program
* Confirm the retest dates for (b)(4) using the revalidated stability-indicating method. This reassessment should ensure that all previously assigned retest dates are accurate.
3. Failure to clean equipment to prevent contamination or carry-over of a material that would alter the quality of the intermediates and API beyond the official or other established specifications.
Your firm failed to adequately clean and maintain non-dedicated API manufacturing equipment used to manufacture as many as (b)(4) different APIs. For example, our investigator observed (b)(4) and (b)(4) particles on product contact surfaces, including the lid and (b)(4) of (b)(4), and (b)(4) liquid draining from the (b)(4) even though the (b)(4) was documented as "empty and cleaned." Additionally, your firm failed to maintain cleaning records for a non-dedicated (b)(4) product transfer pipe.
Your cleaning verification report for (b)(4) addressed only batch-to-batch cleaning. It did not address product changeover. It also lacked scientific justification for product selection and residue limit calculations based on solubility, difficulty of cleaning, and toxicity, as required by your cleaning validation procedure. Your firm affirmed to our investigator that no formal cleaning validation has been performed and that you have not established a maximum allowable carryover limit as required by your procedure.
In your response, you attribute the observed residues on the (b)(4) to the previous batch of the same non-U.S. API, explaining that only a "gross cleaning" is performed between batches during a (b)(4). You conclude there was no risk of carryover. You assert that the (b)(4) transfer pipe is dedicated to a (b)(4) and also conclude there is no cross-contamination risk and confirm you do not use cleaning logs.
Furthermore, you state that you "executed cleaning validation/verification activities for selected products" manufactured on shared equipment.
Your response is inadequate because it does not provide assurance that your cleaning processes are adequate to prevent cross-contamination and carryover risks. It addresses only the (b)(4) particles observed in the (b)(4), attributing them to a non-U.S. API campaign, while failing to test the observed (b)(4) liquid and other particle deposits. You did not expand your investigation to other equipment or conduct a retrospective review of released batches to assess product impact.
Your claim that the (b)(4) transfer pipe is dedicated to a (b)(4) is unsubstantiated and contradicts information provided during the inspection. Further, you do not explain why cleaning validation was limited to selected products, nor do you provide supporting documentation to support or demonstrate that your cleaning practices adequately remove product residues.
Inadequately cleaned and maintained manufacturing equipment can lead to potential cross-contamination that could compromise your API's quality and safety.
In response to this letter, provide:
* A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment of whether cross-contaminated products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices and encompass each piece of manufacturing equipment used to manufacture intermediates and API products.
* Appropriate improvements to your cleaning validation program with special emphasis on incorporating conditions identified as worst case in your API manufacturing operations. This should include but not be limited to identification and evaluation of all worst-case:
- Drugs with higher toxicities
- Drugs with higher potencies
- Drugs with lower solubility in their cleaning solvents
- Drugs with characteristics that make them difficult to clean
- Swabbing locations for areas that are most difficult to clean
- Maximum hold times before cleaning
* A summary of updated standard operating procedures that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.
CGMP Consultant Recommended
Based upon the nature of the deviations we identified at your firm, you should engage a consultant qualified to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit 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. Your firm's executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
Conclusion
The deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.
FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on June 9, 2026.
Correct any deviations promptly. FDA may withhold approval of new applications or supplements listing your firm as a manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations.
Failure to address any deviations may also result in the FDA continuing to refuse admission of articles manufactured at Almon Healthcare Private Limited located at Plot No 4, Sankalp Industrial Estate, Behind Kerala GIDC, Bavala, Ahmedabad, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3030509366 and ATTN: Jamie Dion.
Sincerely,
/S/ Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/almon-healthcare-private-limited-729291-07132026
FCC Chairman Carr Announces National Security Enforcement Actions
WASHINGTON, July 22 -- The Federal Communications Commission issued the following news release on July 21, 2026:
* * *
Chairman Carr Announces National Security Enforcement Actions
FCC Brings Enforcement Against Drone Company Falsely Claiming to Produce in America and Targets Test Lab Discovered to Have Submitted Copied-and-Pasted Test Results
-
Today, FCC Chairman Brendan Carr announced two enforcement actions to further protect Americans from dangerous devices and untrustworthy labs.
First, the Public Safety and Homeland Security Bureau (PSHSB) and the Office of Engineering and Technology ... Show Full Article WASHINGTON, July 22 -- The Federal Communications Commission issued the following news release on July 21, 2026: * * * Chairman Carr Announces National Security Enforcement Actions FCC Brings Enforcement Against Drone Company Falsely Claiming to Produce in America and Targets Test Lab Discovered to Have Submitted Copied-and-Pasted Test Results - Today, FCC Chairman Brendan Carr announced two enforcement actions to further protect Americans from dangerous devices and untrustworthy labs. First, the Public Safety and Homeland Security Bureau (PSHSB) and the Office of Engineering and Technology(OET) began proceedings to revoke two equipment authorizations recently granted to Odyssey Robot for falsely claiming to produce its drone in the U.S. Late last year, following an Executive Branch determination that foreign-made drones pose unacceptable national security risks, the FCC added such drones to the Covered List--banning them from new authorizations. Today's action marks the first revocation proceeding against a drone company trying to evade our rules.
Second, OET instituted proceedings to withdraw recognition from a test lab that repeatedly falsified test results in equipment authorization applications. Before any electronic device can be marketed or sold in the U.S., it must be tested at a lab recognized by the FCC. Since last year, the FCC has been expelling from its equipment authorization system "bad labs" that pose national security risks and/or are untrustworthy. Today's proceeding against Shenzhen STS Test Services, based in Shenzhen, China, outlines how the lab relied on copied-and-pasted duplicate test results for 40 separate products, from smartphones to tablets to car diagnostic tools. This follows OET's instituting proceedings last month against another lab SLG-CPC Test Laboratory Co., Ltd. based in Dongguan, China.
Chairman Carr issued the following statement:
"The FCC's national security enforcement is firing on all cylinders, as today's actions make clear. Our drone revocation proceeding sends a message that the FCC will not allow companies that produce abroad to evade the FCC's prohibition. And our device testing withdrawal proceeding is a reminder why our 'Bad Labs' work is so critical. I want to thank the FCC's Council on National Security for its excellent work on these actions, including the Public Safety and Enforcement Bureaus, alongside the Office of Engineering and Technology."
Additional Background on Odyssey Robot:
Last December, the FCC received an Executive Branch national security determination that drones and drone components produced in foreign countries pose unacceptable risks to the national security of the U.S. or the security and safety of U.S. persons. The FCC then updated the Covered List to include foreign-produced drones--subject to some exceptions. Equipment on the FCC's Covered List cannot be authorized for importation, marketing, or sale in the U.S., so the FCC's action functionally banned new models of foreign-made drones from entering the U.S. market. Since then, the FCC has seen over $4 billion dollars in investment in U.S. drone manufacturing, tens of billions of dollars in capital raised by U.S. drone companies, and thousands of manufacturing jobs created.
Earlier this year, Odyssey Robot received an equipment authorization for its drone and drone remote controller, claiming these devices were not "covered" and listing a Texas-based company as the assembler, eTak Worldwide Corp. eTak, however, is an electronics recycling company, not a drone manufacturer and has no record of any dealings with Odyssey at all. PSHSB and OET today used their authority under Commission rules to bring a streamlined revocation proceeding for equipment authorizations granted on the basis of a false statement that the equipment is not covered equipment.
Additional Background Information on Shenzhen STS Testing Services:
To import, market, or sell electronic devices in the United States, device makers generally must get their devices tested and certified in FCC-recognized test labs and telecommunications certification bodies. These entities play a vital role in ensuring that devices operate at safe power levels, on appropriate spectrum bands that do not create harmful interference and adhere to U.S. government national security rules. Through its investigation, OET discovered that 40 separate FCC IDs (see list below) had apparently relied on identical test reports prepared by Shenzhen STS Test Services, often for wholly different products, such as a PC and wireless earbuds. When confronted, Shenzhen STS Test Services conceded that it had submitted falsified reports, which it blamed on, among other factors, "engineers' negligence...as well as the negligence of the relevant report editors/reviewers."
Today's action follows a series of Commission actions against "bad labs" in our equipment authorization program. Last May, the FCC adopted rules to prohibit the recognition of test labs owned by, or subject to the direction or control of, a foreign adversary country. Since these rules went into effect, the Commission has denied recognition to, or withdrawn recognition from, 23 such test labs. In April of this year, the FCC proposed to restore reciprocity to lab testing by withdrawing recognition from any test lab based in a country that lacks a reciprocal agreement with the U.S. Finally, last month, OET began proceedings against SLG-CPC, another test lab that OET discovered had submitted false, copied-and-pasted test results.
40 FCC IDs:
(a) FCC ID 2BSW8-WAVE10 (4G smartphone), FCC ID 2A8T7ELINK (Bluetooth vehicle diagnostic tool), and FCC ID 2ANWFET9150 (automotive diagnostic system);
(b) FCC ID 2BTXF-WT1PRO (tablet), FCC ID 2A2P5-OHR627 (wireless headset), and FCC ID 2BU9HAW101ANRISLEEP (sleep monitor);
(c) FCC ID 2A2P5-OHR640 (wireless earbuds) and FCC ID 2AXUD-G3S (mini PC);
(d) FCC ID 2A2P5-OHR621 (wireless headset), FCC ID 2ANMU-G7 (smartphone), and FCC ID 2BOHY-851P2-C (Bluetooth module);
(e) FCC ID 2BOHY-621U1 and FCC ID 2BSW8-FORT200 (smartphone);
(f) FCC ID 2A33N-L61A (smartphone) and FCC ID 2BOHY-851P2-M (Bluetooth module);
(g) FCC ID 2A2P5-1-OHR554 (wireless headset) and FCC ID 2BSW8-FORT5 (smartphone);
(h) FCC ID 2A58W-MP10 (wireless earbuds) and FCC ID 2BSW8-ZENO5 (tablet);
(i) FCC ID 2A2P5-OHR621 (wireless headset), FCC ID 2ANMU-G6 (smartphone), and FCC ID 2BTTZORATOR (visel glasses);
(j) FCC ID 2AQRE-SR800 (smart POS terminal) and FCC ID 2BVA8-H1503BQ (LTE module);
(k) FCC ID 2A2P5-OHR804 (wireless earbuds) and FCC ID 2BSW8-ROCK5 (smartphone);
(l) FCC ID 2A2P5-OHR718 (wireless headset) and FCC ID WWE-2IHSK1016 (4-in-1 home speaker);
(m) FCC ID 2A2P5-OHR626 (wireless headset) and FCC ID 2BDS8-X7S (car media player);
(n) FCC ID 2ATH7-U987Q (Bluetooth adapter) and FCC ID 2BUN4-ACT2631 (wireless headphones);
(o) FCC ID 2A33N-L61B (smartphone) and FCC ID 2BSW8-MEGA5 (tablet);
(p) FCC ID 2A2P5-OHR810 (wireless neckband earphones) and FCC ID 2BU85-T20 (tablet);
(q) FCC ID 2A2P5-OHR811 (wireless neckband earphones) and FCC ID 2BU85-T90 (tablet);
(r) FCC ID 2A2P5-OHR626 (wireless headset) and FCC ID 2BSW8-ROCK3 (smartphone);
(s) FCC ID 2A2P5-OHR718 (Bluetooth headset) and FCC ID WWE-2IHSK1016 (4-in-1 home speaker); and
(t) FCC ID 2A2P5-OHR626 (wireless headset) and FCC ID 2BDS8-X7S (car media player).
* * *
Original text here: https://docs.fcc.gov/public/attachments/DOC-423255A1.pdf
* * *
Chairman Carr Announces National Security Enforcement Actions
FCC Brings Enforcement Against Drone Company Falsely Claiming to Produce in America and Targets Test Lab Discovered to Have Submitted Copied-and-Pasted Test Results
-
Today, FCC Chairman Brendan Carr announced two enforcement actions to further protect Americans from dangerous devices and untrustworthy labs.
First, the Public Safety and Homeland Security Bureau (PSHSB) and the Office of Engineering and Technology ... Show Full Article WASHINGTON, July 22 -- The Federal Communications Commission issued the following news release on July 21, 2026: * * * Chairman Carr Announces National Security Enforcement Actions FCC Brings Enforcement Against Drone Company Falsely Claiming to Produce in America and Targets Test Lab Discovered to Have Submitted Copied-and-Pasted Test Results - Today, FCC Chairman Brendan Carr announced two enforcement actions to further protect Americans from dangerous devices and untrustworthy labs. First, the Public Safety and Homeland Security Bureau (PSHSB) and the Office of Engineering and Technology(OET) began proceedings to revoke two equipment authorizations recently granted to Odyssey Robot for falsely claiming to produce its drone in the U.S. Late last year, following an Executive Branch determination that foreign-made drones pose unacceptable national security risks, the FCC added such drones to the Covered List--banning them from new authorizations. Today's action marks the first revocation proceeding against a drone company trying to evade our rules.
Second, OET instituted proceedings to withdraw recognition from a test lab that repeatedly falsified test results in equipment authorization applications. Before any electronic device can be marketed or sold in the U.S., it must be tested at a lab recognized by the FCC. Since last year, the FCC has been expelling from its equipment authorization system "bad labs" that pose national security risks and/or are untrustworthy. Today's proceeding against Shenzhen STS Test Services, based in Shenzhen, China, outlines how the lab relied on copied-and-pasted duplicate test results for 40 separate products, from smartphones to tablets to car diagnostic tools. This follows OET's instituting proceedings last month against another lab SLG-CPC Test Laboratory Co., Ltd. based in Dongguan, China.
Chairman Carr issued the following statement:
"The FCC's national security enforcement is firing on all cylinders, as today's actions make clear. Our drone revocation proceeding sends a message that the FCC will not allow companies that produce abroad to evade the FCC's prohibition. And our device testing withdrawal proceeding is a reminder why our 'Bad Labs' work is so critical. I want to thank the FCC's Council on National Security for its excellent work on these actions, including the Public Safety and Enforcement Bureaus, alongside the Office of Engineering and Technology."
Additional Background on Odyssey Robot:
Last December, the FCC received an Executive Branch national security determination that drones and drone components produced in foreign countries pose unacceptable risks to the national security of the U.S. or the security and safety of U.S. persons. The FCC then updated the Covered List to include foreign-produced drones--subject to some exceptions. Equipment on the FCC's Covered List cannot be authorized for importation, marketing, or sale in the U.S., so the FCC's action functionally banned new models of foreign-made drones from entering the U.S. market. Since then, the FCC has seen over $4 billion dollars in investment in U.S. drone manufacturing, tens of billions of dollars in capital raised by U.S. drone companies, and thousands of manufacturing jobs created.
Earlier this year, Odyssey Robot received an equipment authorization for its drone and drone remote controller, claiming these devices were not "covered" and listing a Texas-based company as the assembler, eTak Worldwide Corp. eTak, however, is an electronics recycling company, not a drone manufacturer and has no record of any dealings with Odyssey at all. PSHSB and OET today used their authority under Commission rules to bring a streamlined revocation proceeding for equipment authorizations granted on the basis of a false statement that the equipment is not covered equipment.
Additional Background Information on Shenzhen STS Testing Services:
To import, market, or sell electronic devices in the United States, device makers generally must get their devices tested and certified in FCC-recognized test labs and telecommunications certification bodies. These entities play a vital role in ensuring that devices operate at safe power levels, on appropriate spectrum bands that do not create harmful interference and adhere to U.S. government national security rules. Through its investigation, OET discovered that 40 separate FCC IDs (see list below) had apparently relied on identical test reports prepared by Shenzhen STS Test Services, often for wholly different products, such as a PC and wireless earbuds. When confronted, Shenzhen STS Test Services conceded that it had submitted falsified reports, which it blamed on, among other factors, "engineers' negligence...as well as the negligence of the relevant report editors/reviewers."
Today's action follows a series of Commission actions against "bad labs" in our equipment authorization program. Last May, the FCC adopted rules to prohibit the recognition of test labs owned by, or subject to the direction or control of, a foreign adversary country. Since these rules went into effect, the Commission has denied recognition to, or withdrawn recognition from, 23 such test labs. In April of this year, the FCC proposed to restore reciprocity to lab testing by withdrawing recognition from any test lab based in a country that lacks a reciprocal agreement with the U.S. Finally, last month, OET began proceedings against SLG-CPC, another test lab that OET discovered had submitted false, copied-and-pasted test results.
40 FCC IDs:
(a) FCC ID 2BSW8-WAVE10 (4G smartphone), FCC ID 2A8T7ELINK (Bluetooth vehicle diagnostic tool), and FCC ID 2ANWFET9150 (automotive diagnostic system);
(b) FCC ID 2BTXF-WT1PRO (tablet), FCC ID 2A2P5-OHR627 (wireless headset), and FCC ID 2BU9HAW101ANRISLEEP (sleep monitor);
(c) FCC ID 2A2P5-OHR640 (wireless earbuds) and FCC ID 2AXUD-G3S (mini PC);
(d) FCC ID 2A2P5-OHR621 (wireless headset), FCC ID 2ANMU-G7 (smartphone), and FCC ID 2BOHY-851P2-C (Bluetooth module);
(e) FCC ID 2BOHY-621U1 and FCC ID 2BSW8-FORT200 (smartphone);
(f) FCC ID 2A33N-L61A (smartphone) and FCC ID 2BOHY-851P2-M (Bluetooth module);
(g) FCC ID 2A2P5-1-OHR554 (wireless headset) and FCC ID 2BSW8-FORT5 (smartphone);
(h) FCC ID 2A58W-MP10 (wireless earbuds) and FCC ID 2BSW8-ZENO5 (tablet);
(i) FCC ID 2A2P5-OHR621 (wireless headset), FCC ID 2ANMU-G6 (smartphone), and FCC ID 2BTTZORATOR (visel glasses);
(j) FCC ID 2AQRE-SR800 (smart POS terminal) and FCC ID 2BVA8-H1503BQ (LTE module);
(k) FCC ID 2A2P5-OHR804 (wireless earbuds) and FCC ID 2BSW8-ROCK5 (smartphone);
(l) FCC ID 2A2P5-OHR718 (wireless headset) and FCC ID WWE-2IHSK1016 (4-in-1 home speaker);
(m) FCC ID 2A2P5-OHR626 (wireless headset) and FCC ID 2BDS8-X7S (car media player);
(n) FCC ID 2ATH7-U987Q (Bluetooth adapter) and FCC ID 2BUN4-ACT2631 (wireless headphones);
(o) FCC ID 2A33N-L61B (smartphone) and FCC ID 2BSW8-MEGA5 (tablet);
(p) FCC ID 2A2P5-OHR810 (wireless neckband earphones) and FCC ID 2BU85-T20 (tablet);
(q) FCC ID 2A2P5-OHR811 (wireless neckband earphones) and FCC ID 2BU85-T90 (tablet);
(r) FCC ID 2A2P5-OHR626 (wireless headset) and FCC ID 2BSW8-ROCK3 (smartphone);
(s) FCC ID 2A2P5-OHR718 (Bluetooth headset) and FCC ID WWE-2IHSK1016 (4-in-1 home speaker); and
(t) FCC ID 2A2P5-OHR626 (wireless headset) and FCC ID 2BDS8-X7S (car media player).
* * *
Original text here: https://docs.fcc.gov/public/attachments/DOC-423255A1.pdf