Featured Stories
White House: First Lady Melania Trump's Special Visit to Ashe County, North Carolina Bearing Witness to a Community's Resilience
WASHINGTON, Sept. 16 -- The White House issued the following news:
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First Lady Melania Trump's Special Visit to Ashe County, North Carolina Bearing Witness to a Community's Resilience
September 15, 2026
First Lady Melania Trump returned to North Carolina to visit Mountain View Elementary School in Ashe County, nearly two years after her initial visit to a community devastated by Hurricane Helene.
"True resilience means having the courage to look ahead and move society forward, creating a better future," the First Lady said.
This visit shared a different story: one of resilience and a
... Show Full Article
WASHINGTON, Sept. 16 -- The White House issued the following news:
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First Lady Melania Trump's Special Visit to Ashe County, North Carolina Bearing Witness to a Community's Resilience
September 15, 2026
First Lady Melania Trump returned to North Carolina to visit Mountain View Elementary School in Ashe County, nearly two years after her initial visit to a community devastated by Hurricane Helene.
"True resilience means having the courage to look ahead and move society forward, creating a better future," the First Lady said.
This visit shared a different story: one of resilience and acommunity determined to move forward. Mrs. Trump's return denoted a new chapter in the western North Carolina regional recovery. Her first visit came in the immediate aftermath of the disaster, when the focus was on comforting survivors, thanking first responders, and confronting the extraordinary destruction left behind.
Mrs. Trump highlighted the forward-looking spirit of North Carolinians affected by Hurricane Helene, and their accelerated journey to the forefront of artificial intelligence technology.
Joining the First Lady at Mountain View Elementary was Carrie Robledo, a North Carolina second-grade teacher and 2026 Presidential AI Challenge National Champion. Mrs. Trump praised Ms. Robledo's innovative work introducing young students to artificial intelligence.
"Ms. Robledo built something that no hurricane can destroy, and no flood can wash away: knowledge. And knowledge is power," the First Lady said.
First Lady Melania Trump's inaugural Presidential AI Challenge became the most expansive federally led artificial intelligence competition in American history, engaging more than 20,000 participants from all 50 states.
"That is the lasting spirit of America. We may face hard times, but we do not fail. We choose to grow--like a rare young flower pushing through the cold earth after a storm," said the First Lady--celebrating the strength of a community that did not want to be defined by disaster and reflecting on Ashe County's recovery.
Finally, The First Lady delighted students, teachers, and administrators with a special gift. BE BEST Fostering the Future, NVIDIA, and StudyFetch gifted 1,500 students AI Literacy training licenses and 100 Robotics Learning Kits powered by Jetson Nano. These new tools allow students to explore artificial intelligence and physical AI, develop technical skills, and bring their creative ideas to life.
The First Lady's remarks, as prepared for delivery, are below.
North Carolina is the Definition of Resilience
Hello everyone and thank you for welcoming me back to North Carolina. It's such an honor to meet the inspirational people from Ashe County and Mountain View Elementary School. I am so proud of you all.
To Dr. Cox, Mr. Graybeal, educators, students, administrators, and the brave families of Mountain View, thank you for welcoming me here today. Your story is incredible.
North Carolina is the definition of resilience.
Toughness in times of adversity is ingrained in the Tar Heel State's character. It is easy to discover resilience within the courage of Ashe County's families, the strength of this community, and the determination of its people to rise when needed.
Almost two years ago, Hurricane Helene hit North Carolina with incredible force. Record-breaking rainfall led your state legislature to describe it as "multiple 1,000-year flood events." Hundreds of roads and bridges were damaged or destroyed. Over one million people lost power, and many neighborhoods lost water, communications, and other vital services. Including, Ashe County.
Tragically, 108 lives were lost.
For children here at Mountain View Elementary, the storm took away much more than just your daily routine. Your neighborhood was flooded and your school was transformed into a distribution center. For too many kids across the state, the familiar daily routines of classrooms, teachers, and friends were suddenly gone.
But, as the water levels rose, you stepped up for one another. Families welcomed others into their homes, brave individuals rushed toward the danger to assist, and faith leaders gave comfort.
Teachers became anchors of stability, and your school turned into more than a place to learn. It turned into a lifeline, providing food, water, supplies, counseling, and hope.
Mountain View's Assistant Principal Cynthia Harless is an American hero. When Hurricane Helene struck, Cynthia drove to check on the school. Soon thereafter, floodwaters washed away the roads, leaving Cynthia and her family unable to return home. Rather than focus on her own hardship, she spent the next four weeks volunteering at Mountain View Elementary's distribution center, providing critical supplies to families and neighbors in need.
All of America saw your town's strength, Mountain View.
Resilience, however, is more than just being strong and rebuilding what was lost. True resilience means having the courage to look ahead and move society forward, creating a better future for our children.
And less than two years after Helene, North Carolina did just that.
Through the Presidential AI Challenge, students and teachers from North Carolina took the national stage, inspired by what's possible. One of America's 2026 Presidential AI Challenge National Champions came from right here in North Carolina.
Ms. Carrie Robledo, a second-grade teacher at Star Elementary School, created "AI Insect Detectives." She introduced young children to artificial intelligence using science, curiosity, and the natural world. Ms. Robledo traveled three hours to meet us here today. Carrie, you are a national champion - please come up and join me.
Think about that remarkable journey: from floodwaters to the cutting edge of artificial intelligence. Ms. Robledo built something that no hurricane can destroy and no flood can wash away: knowledge.
And Knowledge is power.
Knowledge gives everyone in this town the chance to move beyond Helene and to imagine new possibilities. It gives the next generation the choice to help create a beautiful world in the future--a better America.
That is the lasting spirit of America. We may face hard times, but we do not fail. We choose to grow like a rare young flower pushing through the cold earth after a storm.
North Carolina has shown that resilience can blossom even in the most difficult times. In this community, the storm didn't have the final word.
Ashe County and Mountain View Elementary--you are the spirit of America! It is wonderful to be with all of the students at Mountain View today. You kids are the stars!
Shortly, I will visit your classrooms, and I cannot wait to see what you have been learning
I am especially excited to hear about your work with AI. As you begin this new school year, remember to take your education seriously, stay curious, and always challenge yourself. And, I have a special surprise to help jumpstart that curiosity.
BE BEST Fostering the Future and Nvidia have joined together to provide 1500 students in Ashe County with Study Fetch subscriptions. We have also arranged to provide 100 Jetson Nano Developer Kits for the young ones here at Mountain View Elementary as well as for other schools in the district. Dream big and use these AI tools to build something never created before. Maybe one of you will create the next great robot. And if you do, make sure you bring it to the White House to show me!
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Original text here: https://www.whitehouse.gov/briefings-statements/2026/09/first-lady-melania-trumps-special-visit-to-ashe-county-north-carolina-bearing-witness-to-a-communitys-resilience/
USDA: 'Report on National Finance Center's Description of Its Payroll and Personnel Systems and the Suitability of the Design and Operating Effectiveness of Its Controls for the Period October 1, 2025 Through June 30, 2026'
WASHINGTON, Sept. 16 (TNSLrpt) -- The Agriculture Inspector General issued the following audit report (No. 11303-0010-12) on September 11, 2026, entitled "Independent Service Auditor's Report on National Finance Center's Description of Its Payroll and Personnel Systems and the Suitability of the Design and Operating Effectiveness of Its Controls for the period October 1, 2025 through June 30, 2026."
Here are excerpts:
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This report presents the results of the System and Organization Controls 1 Type 2 examination conducted in accordance with relevant attestation standards established by the
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WASHINGTON, Sept. 16 (TNSLrpt) -- The Agriculture Inspector General issued the following audit report (No. 11303-0010-12) on September 11, 2026, entitled "Independent Service Auditor's Report on National Finance Center's Description of Its Payroll and Personnel Systems and the Suitability of the Design and Operating Effectiveness of Its Controls for the period October 1, 2025 through June 30, 2026."
Here are excerpts:
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This report presents the results of the System and Organization Controls 1 Type 2 examination conducted in accordance with relevant attestation standards established by theAmerican Institute of Certified Public Accountants for the United States Department of Agriculture's (USDA) National Finance Center (NFC) description of its payroll and personnel system for processing user entities' payroll and human resources transactions throughout the period October 1, 2025, to June 30, 2026. The report contains an unmodified opinion on the description and controls that were suitably designed to provide reasonable assurance that the control objectives would be achieved.
An independent certified public accounting firm conducted the audit. In connection with the contract, we reviewed the independent firm's report and related documentation and inquired of its representatives. Our review, as differentiated from an audit in accordance with Government Auditing Standards (issued by the Comptroller General of the United States), was not intended to enable us to express, and we do not express, opinions on the USDA NFC's description of its payroll and personnel system for processing user entities' payroll and human resources transactions throughout the period October 1, 2025, to June 30, 2026. The independent firm is responsible for the attached auditor's report, dated September 1, 2026, and the conclusions expressed in the report. However, our review disclosed no instances where the independent firm did not comply, in all material respects, with Government Auditing Standards, issued by the Comptroller General of the United States, and relevant attestation standards established by the American Institute of Certified Public Accountants.
This report contains sensitive information that is being withheld from public release due to concerns about the risk of circumvention of law.
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The report is posted at: https://www.oig.usda.gov/sites/default/files/reports/2026-09/11303-0010-12_FR_508_FOIA_redacted_public.pdf
Postal Service IG: Processing of Election and Political Mail for the 2026 Primary Elections
WASHINGTON, Sept. 16 (TNSLrpt) -- The U.S. Postal Service Inspector General issued the following audit report (No. 26-054-R26) on September 4, 2026, entitled "Processing of Election and Political Mail for the 2026 Primary Elections."
Here are excerpts:
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Background
The U.S. Postal Service handles the processing, transportation, and delivery of Election and Political Mail across the country. It is committed to fulfilling its role in the electoral process when policymakers and voters choose to use the mail as part of their election systems or as their means to vote, respectively. To do so,
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WASHINGTON, Sept. 16 (TNSLrpt) -- The U.S. Postal Service Inspector General issued the following audit report (No. 26-054-R26) on September 4, 2026, entitled "Processing of Election and Political Mail for the 2026 Primary Elections."
Here are excerpts:
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Background
The U.S. Postal Service handles the processing, transportation, and delivery of Election and Political Mail across the country. It is committed to fulfilling its role in the electoral process when policymakers and voters choose to use the mail as part of their election systems or as their means to vote, respectively. To do so,the Postal Service aims to employ practices and procedures to help ensure that it meets its customers' expectations -- that Election Mail, especially Ballot Mail, will be delivered timely. On March 31, 2026, an Executive Order was issued pertaining to election administration, and related litigation is ongoing at the time of this report issuance. This audit did not evaluate the Postal Service's plan to implement this order, but we plan to cover allegations received at the end of August 2026 in subsequent work.
What We Did
Our objective was to evaluate the Postal Service's processing of Election and Political Mail for the 2026 primary elections. We conducted observations at nine processing facilities and 73 delivery units in eight states during primary elections from March to May 2026. In June 2026, we conducted further observations at five mail processing facilities in New Jersey and Tennessee, in response to a congressional inquiry.
What We Found
From February through May 2026, the Postal Service processed Election and Political Mail with on-time processing scores ranging from 97.75 to 98.99 percent. While most facilities we visited generally adhered to Postal Service's election-related policies and procedures, there are opportunities to increase understanding and enforcement of postmarking ballots, completing required reports for late arriving Political Mail and the daily all-clear certifications, and posting election-related training materials for employees. Additionally, we found coordination with election officials and communication with customers affected by operational changes could be strengthened. Further, we identified opportunities at specific mail processing facilities that, if employed, could support the timely delivery of Ballot Mail.
Recommendations and Management's Comments
We made 11 recommendations to address the issues identified in the report. Postal Service management agreed with 10 and disagreed with one. While the Postal Service disagreed with one recommendation, the U.S. Postal Service Office of Inspector General considers management's comments responsive to all recommendations, as corrective actions should resolve the issues identified in the report.
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View the original text at: https://www.uspsoig.gov/sites/default/files/reports/2026-09/26-054-r26_0.pdf
Postal Service IG: Assessment of Postal Service's Network Changes
WASHINGTON, Sept. 16 (TNSLrpt) -- The U.S. Postal Service Inspector General issued the following audit report (No. 26-042-R26) on September 8, 2026, entitled "Assessment of Postal Service's Network Changes."
Here are excerpts:
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Background
In March 2021, the U.S. Postal Service released its 10-year strategic Delivering for America (DFA) plan to achieve financial sustainability and improve service. Since that time, the Postal Service has implemented significant changes in its transportation, package processing, and delivery network. This involved reducing operational costs by consolidating
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WASHINGTON, Sept. 16 (TNSLrpt) -- The U.S. Postal Service Inspector General issued the following audit report (No. 26-042-R26) on September 8, 2026, entitled "Assessment of Postal Service's Network Changes."
Here are excerpts:
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Background
In March 2021, the U.S. Postal Service released its 10-year strategic Delivering for America (DFA) plan to achieve financial sustainability and improve service. Since that time, the Postal Service has implemented significant changes in its transportation, package processing, and delivery network. This involved reducing operational costs by consolidatingoperations and moving mail from air networks to ground transportation, eliminating duplicate and unneeded routes. Additionally, the Postal Service implemented several service standard changes to enable network changes and improve on-time delivery.
What We Did
Our objective was to determine the impacts that network change initiatives have had on the Postal Service and its stakeholders. For this audit, we focused on cost, savings, and service performance impacts of the Postal Service's network processing, transportation, and delivery initiatives from fiscal year (FY) 2016 through FY 2026, quarter 2.
What We Found
The Postal Service has made significant changes to its network in the first five years of the DFA plan reducing mail processing, transportation, and delivery costs. However, the financial position of the Postal Service has not improved, and the operational changes have coincided with service performance declines, with rural communities experiencing the most noticeable impacts. Additionally, the Postal Service does not have a long-term cost savings target nor does it track the financial impact of network change initiatives. Instead, it manages initiatives on an annual basis but does not have an overall program schedule and timeline to track and report long-term progress. We also found issues with network changes that could have been identified through better planning and modeling.
Finally, the organization is missing an opportunity to better standardize the network of facilities envisioned at the outset of the DFA plan. As a result, the Postal Service continues to operate a fragmented system that hampers nationwide decision-making, limits expected efficiencies, and complicates efforts to measure performance.
Recommendations and Management's Comments
We made five recommendations to address the issues identified in the report, and management agreed with all five recommendations. We consider management's comments responsive as corrective actions should resolve the issues identified in the report.
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View the original text at: https://www.uspsoig.gov/sites/default/files/reports/2026-09/26-042-r26.pdf
OMB Issues Statement of Administration Policy on Joint Resolution Disapproving EPA Commercial Harbor Craft Rule
WASHINGTON, Sept. 16 -- The White House Office of Management and Budget issued the following statement of administration policy on Sept. 15, 2026, on a joint resolution (H.J.Res. 213) that provides for Congressional disapproval of a rule submitted by the Environmental Protection Agency relating to "California State Nonroad Engine Pollution Control Standards; Commercial Harbor Craft Regulations; Notice of Decision".
The resolution was introduced by Rep. Mike Gallagher, R-Wisconsin, and five cosponsors.
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The Administration strongly supports passage of H.J. Res. 213, which would disapprove
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WASHINGTON, Sept. 16 -- The White House Office of Management and Budget issued the following statement of administration policy on Sept. 15, 2026, on a joint resolution (H.J.Res. 213) that provides for Congressional disapproval of a rule submitted by the Environmental Protection Agency relating to "California State Nonroad Engine Pollution Control Standards; Commercial Harbor Craft Regulations; Notice of Decision".
The resolution was introduced by Rep. Mike Gallagher, R-Wisconsin, and five cosponsors.
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The Administration strongly supports passage of H.J. Res. 213, which would disapprovea waiver issued by the Environmental Protection Agency relating to "California State Nonroad Engine Pollution Control Standards; Commercial Harbor Craft Regulations; Notice of Decision."
The Clean Air Act allows California to seek a waiver of the Act's preemption of state regulation of emissions from new nonroad engines and vehicles, if certain conditions are met. The previous Administration granted the California Air Resources Board's amendments to its Commercial Harbor Craft regulation without submitting it to Congress for review. The Harbor Craft amendments establish emissions requirements for commercial vessels operating in California waters and expands this regulation to additional vessel categories, including ferries, workboats, and commercial fishing vessels, while imposing strict new engine standards and zero-emission requirements.
The Harbor Craft amendments impose burdensome and unrealistic zero-emission requirements on vessels. The maritime industry has faced economic hardship while trying to comply, and Americans have suffered through maritime jobs being threatened and prices being raised on goods shipped by sea. The Administration supports stopping California from imposing unlawful, unachievable policies that weaken American competitiveness and further strain the nation's supply chains.
If H.J. Res. 213 were presented to the President, his advisors would recommend that he sign it into law.
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Original text here: https://www.whitehouse.gov/wp-content/uploads/2026/09/SAP-HJR213.pdf
FDA Center for Drug Evaluation & Research Issues Warning Letter to Bausch & Lomb
WASHINGTON, Sept. 16 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Bausch and Lomb Inc. from its Center for Drug Evaluation and Research:
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Recipient: Mr. Robert T. Fulop, Director of Site Operations, Bausch & Lomb Inc., 8500 Hidden River Parkway, Tampa, FL 33637-1014, United States
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
Reference number: 320-26-123
To Mr. Robert T. Fulop:
This warning letter advises you of significant violations observed during a U.S. Food
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WASHINGTON, Sept. 16 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Bausch and Lomb Inc. from its Center for Drug Evaluation and Research:
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Recipient: Mr. Robert T. Fulop, Director of Site Operations, Bausch & Lomb Inc., 8500 Hidden River Parkway, Tampa, FL 33637-1014, United States
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
Reference number: 320-26-123
To Mr. Robert T. Fulop:
This warning letter advises you of significant violations observed during a U.S. Foodand Drug Administration (FDA) inspection of your facility. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
FDA Inspection
Violations were observed and documented during an inspection of your drug manufacturing facility, Bausch & Lomb Inc., FDA Establishment Identifier (FEI) 1000113778, at 8500 Hidden River Parkway, Tampa, from March 12 to 20, 2026. This inspection was conducted under FDA's statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your April 10, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.
Violations of the Federal Food, Drug, and Cosmetic Act
The following are violations identified during our inspection and review. As a reminder, this is not an all-inclusive list of violations at your facility.
1. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)).
Inadequate Monitoring of Aseptic Processing
Your firm is a manufacturer of sterile prescription and over-the-counter (OTC) (b)(4) drug products produced by aseptic processing. Your environmental monitoring (EM) program and personnel monitoring (PM) was inadequate for classified areas used to produce your sterile (b)(4) drug products. For example,
* Your program did not sufficiently monitor significant locations (e.g., phones used in the aseptic processing area).
* EM procedures used to evaluate the aseptic processing environment were insufficient.
* Media used to support your EM program was observed to be inadequate to support growth of recovered contamination (e.g., cracked media).
From 2023 to 2025 you routinely recovered microorganisms from aseptic ISO 5 areas (air, surface, and personnel) that were out-of-limit (OOL). Notably, recovered microbes in the aseptic processing environment included gram-negative rods such as Serratia marcescens and Stenotrophomonas maltophilia, organisms frequently associated with water sources, suggesting a moisture-related contamination issue. You continued (b)(4) drug production without adequate corrective action and preventive action (CAPA) measures to address the persistent microbiological contamination in your ISO 5 environments that posed a risk to product sterility.
Manufacturing Design and Unidirectional Airflow
Your restricted access barrier system (RABS) line (b)(4) included design deficiencies, including (b)(4) placement that led to ergonomic difficulties (e.g., when (b)(4) transferring sterilized components (b)(4)). We also noted that line (b)(4) had insufficient barrier protection. In addition, your dynamic smoke studies failed to sufficiently demonstrate unidirectional airflow protection across multiple lines (e.g., during equipment setup and assembly in the filling areas).
Basic design deficiencies and excessive recoveries of microorganisms from ISO 5 areas indicate that there is significant inherent contamination risk in your current operation.
Your response indicates that your aseptic processing operation is in control based on EM data, sterility test results, and foreign matter complaint rates. Your response also states that you have implemented procedural changes for (b)(4) loading and added mandatory disinfection requirements following recovery of fungi or gram-negative rods from ISO 5 and ISO 7 areas.
Overall, your response fails to address how you will ensure adequate aseptic processing operations, proper future assessment of your EM and PM data to support your aseptic processes, and appropriate interpretation and assessment of consumer complaint samples. You also lack a commitment to implement significant design remediations.
It should be noted that a sterility test, while a critical quality control for drug products that purport to be sterile, cannot be solely relied upon as justification to release drug product batches. The test is only the last in a series of design provisions and controls intended to protect the consumer from distribution of an unsafe batch.
The ISO 5 processing environments are critical because sterile products are exposed during aseptic production and therefore vulnerable to contamination if operations are not well designed and diligently controlled. Your aseptic processes should be designed, and operations executed, to prevent contamination hazards to your sterile product. Flaws in the design of cleanrooms and aseptic processing lines, or improper execution of operations, can promote influx of contamination into the critical processing area.
You also failed to adequately investigate microbiological departures from action limits and adverse trends in your water for injection system and environmental and personnel monitoring programs. Your investigations did not evaluate the persistent recovery of microorganisms over time, and you did not perform adequate microorganism identification. Notably, microorganisms recovered from your facility, including Pseudomonas aeruginosa and Aspergillus brasiliensis, were the same genus and species as those recovered from several consumer complaint samples.
In response to this letter, provide:
* An independent, comprehensive review of your EM program to ensure vigilant, timely detection and response to potential product contamination hazards in your manufacturing environment. This assessment should include, but not be limited to, the following:
- Establishing appropriate limits
- Sampling methods
- Sampling locations and frequencies
- Trend analysis
- Appropriate investigation of deviations and adverse trends
- A CAPA plan based on the findings of the assessment
* A comprehensive, independent assessment of the design and control of your firm's manufacturing operations, with a detailed and thorough review of all microbiological hazards.
* A detailed risk assessment addressing the hazards posed by distributing drug products with potentially objectionable contamination. Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls.
* Complete investigations into all batches with potential objectionable microbiological contamination or an OOL microbiological result (whether or not later invalidated). The investigations should detail your findings regarding the root causes of the contamination.
* Appropriate microbiological batch release specifications (i.e., total counts, identification of bioburden to detect objectionable microbes) for each of your drug products.
* All microbiological test methods used to analyze each of your drug products.
* A summary of results from testing retain samples of all drug product batches within expiry. You should test all appropriate quality attributes including, but not limited to, identity and strength of active ingredients and microbiological quality (total counts and identification of bioburden to detect any objectionable microbes) of each batch. If testing yields an OOL result, indicate the corrective actions you will take, including notifying customers and initiating recalls.
* Perform a critical evaluation of airflow unidirectionality in your aseptic process, with the assistance of a qualified consultant. Ensure smoke studies are conducted under dynamic conditions, with thorough and complete evaluations of aseptic processing line airflow unidirectionality, including the impact of dynamic interactions and aseptic interventions. These thorough smoke studies should be performed after you remediate your aseptic operation and conducted using proper practices (e.g., neutrally buoyant media) to appropriately visualize airflow.
2. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
Poor Aseptic Technique and Cleanroom Behavior
Your operators were observed repeatedly exhibiting poor aseptic practices during filling operations on (b)(4) line (b)(4), including, but not limited to, the following:
* Operators reached over exposed (b)(4) bottles while (b)(4) to remove jammed bottles.
* Operators failed to disinfect (b)(4) (e.g., prior to handling sterile supplies and between use of different (b)(4)).
* (b)(4) contacted (b)(4) housing and blocked unidirectional air to open sterilized bottles.
* (b)(4) contacted sterile portions of aseptic tweezers used to remove jammed bottles, and operators returned those bottles back to the (b)(4).
* Bags used to transfer sterile components (bottles) were exposed to the ISO 7 environment prior to manipulation with (b)(4) and contacted internal portions of the (b)(4) housing.
* Operators used (b)(4) to push trash into a receptacle located below the processing line rather than using equipment dedicated for this purpose.
In your response, you commit to updating your personnel training and using (b)(4) aseptic training (b)(4). Your response does not address the failure of the operations and quality unit to detect and require remediation of these significant aseptic processing hazards. Your response also fails to address how your operations and quality unit will proactively oversee and maintain ongoing control over aseptic conditions, processes, and finished product.
Other aseptic line deficiencies were also observed during our inspection. For example, line (b)(4) included aseptic setup hazards related to personnel and line design that could compromise the sterility of product contact equipment.
In addition, your process simulations (media fill) were inadequate. Data indicated that the total number of units in your media fills were substantially smaller than your aseptically produced commercial batch sizes and did not sufficiently represent the contamination risks associated with your aseptic processing lines. Significantly, you documented a media fill failure on line 16 in July 2025, in which two units demonstrated fungal (Neovaginatispora magiferae) and spore forming gram-positive Geodermatophilus obscurus, contamination, respectively.
See FDA's guidance document Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing at https://www.fda.gov/media/71026/download.
In response to this letter, provide:
* A comprehensive, independent risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, including but not limited to, the following:
- All human interactions within the ISO 5 area (e.g., risk reduction or elimination of manual interventions wherever possible)
- Equipment suitability (e.g., reliability, capability, ergonomics, placement) and sufficient cleanroom space
- Air quality in the ISO 5 area and surrounding room including, but not limited to, air volume and flow
- Facility layout
- Personnel flow and material flow (movement throughout all rooms used to conduct and support sterile operations, and all material transfers)
- Specific CAPA recommendations that will comprehensively address the design and control hazards identified in the risk assessment
* A detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe specific tangible improvements to be made to aseptic processing operation design and control at your facility and explain how this CAPA plan will robustly remediate your deficient sterile manufacturing operations. Include comprehensive changes to the design of (b)(4) aseptic processing lines and cleanrooms. Also, describe your plans for qualification and validation of your extensively remediated operations.
* Your systematic plan to assure adherence to appropriate aseptic practices, cleanroom behavior, and written procedures, including but not limited to an independent assessment of the following with accompanying CAPA:
- Suitability of actual practices based on extensive retrospective review and prospective observation of aseptic processing operations
- Deficiencies in production management oversight, and identification of specific improvements to ensure effective and routine supervisory oversight for all batches
- Frequency and depth of quality unit oversight (e.g., audit, ad hoc, daily interactions) of aseptic processing and its support operations
- Adequacy of written procedures
Ineffective Quality System
Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production operations, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. 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.
Request for a Meeting with FDA
After you submit your response to this warning letter, we recommend you reach out to this office to arrange for a teleconference to discuss your corrective actions and preventive actions in detail. Direct your request to Kathryn Hall Kathryn.Hall@fda.hhs.gov and cc: CDER-OC-OMQ-Communications@fda.hhs.gov.
Conclusion
You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.
Unresolved violations may prevent other Federal agencies from awarding contracts. Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.
If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER's Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356c(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.
Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of receipt of this letter1. Identify your written response with FEI 1000113778 and ATTN: Compliance Officer Matthew R. Dionne, in the letter or /in the subject line of the email.
If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.
FDA posts warning letters to www.FDA.gov.
Sincerely,
/S/ Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
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Footnote:
1/ Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bausch-lomb-inc-732398-09042026
EPA IG: Compendium of Open Recommendations: Data as of May 31, 2026
WASHINGTON, Sept. 16 (TNSLrpt) -- The Environmental Protection Agency Inspector General issued the following report (No. 26-N-0050) entitled "Compendium of Open Recommendations: Data as of May 31, 2026."
Here are excerpts:
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Why We Did This Report
The Inspector General Act of 1978, as amended, requires each inspector general to prepare semiannual reports for Congress. As part of that reporting, the inspector general must identify all recommendations from the prior reporting period for which corrective actions have not been completed by the agency. We are publishing this compendium to provide
... Show Full Article
WASHINGTON, Sept. 16 (TNSLrpt) -- The Environmental Protection Agency Inspector General issued the following report (No. 26-N-0050) entitled "Compendium of Open Recommendations: Data as of May 31, 2026."
Here are excerpts:
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Why We Did This Report
The Inspector General Act of 1978, as amended, requires each inspector general to prepare semiannual reports for Congress. As part of that reporting, the inspector general must identify all recommendations from the prior reporting period for which corrective actions have not been completed by the agency. We are publishing this compendium to providean update on the recommendations that remained open as of May 31, 2026.
Summary of Findings
This compendium provides an update on the 83 resolved recommendations that we identified in our semiannual Report to Congress issued in May 2026. Our update recognizes changes in the status of recommendations that occurred after March 31, 2026, but not later than May 31, 2026.
In that time frame, the EPA completed corrective actions for six of the 83 resolved recommendations listed in the semiannual report; therefore, this update analyzes 77 resolved recommendations, which represent over $265.2 million in potential cost savings. Of those 77 resolved recommendations, 38 will be at least three years old on their scheduled corrective action completion date. These 38 recommendations represent over $33.3 million in potential cost savings.
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The report is posted at: https://www.epa.gov/system/files/documents/2026-09/_epaoig_20260908-26-n-0050_compendium_cert.pdf
