Featured Stories
State Department IG: Independent Accountant's Report on the Application of Agreed-Upon Procedures: Employee Benefits, Withholdings, Contributions, and Supplemental Semiannual Headcount Reporting Submitted to the Office of Personnel Management
WASHINGTON, Oct. 14 (TNSLrpt) -- The State Department Inspector General issued the following audit report (AUD-FM-27-01) entitled "Independent Accountant's Report on the Application of Agreed-Upon Procedures: Employee Benefits, Withholdings, Contributions, and Supplemental Semiannual Headcount Reporting Submitted to the Office of Personnel Management."
Here are excerpts:
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At the direction of the Office of Inspector General (OIG), an independent external auditor performed agreed-upon procedures as outlined by the Office of Management and Budget. These procedures were performed to assist
... Show Full Article
WASHINGTON, Oct. 14 (TNSLrpt) -- The State Department Inspector General issued the following audit report (AUD-FM-27-01) entitled "Independent Accountant's Report on the Application of Agreed-Upon Procedures: Employee Benefits, Withholdings, Contributions, and Supplemental Semiannual Headcount Reporting Submitted to the Office of Personnel Management."
Here are excerpts:
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At the direction of the Office of Inspector General (OIG), an independent external auditor performed agreed-upon procedures as outlined by the Office of Management and Budget. These procedures were performed to assistthe Office of Personnel Management (OPM) in assessing the reasonableness of retirement benefits, health benefits, and life insurance withholdings and contributions as well as enrollment information submitted by the U.S. Department of State in its Semiannual Headcount Report to OPM.
Of the 54 procedures completed, 52 were completed without exception. For one exception, one element of the SF2809 (Federal Employees Health Benefits Program Election Form) did not agree with the earnings and leave statement. For the second exception, one SF-2817 (Life Insurance Election form) was not correctly marked in support of the payroll action.
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View full audit report at: https://www.stateoig.gov/uploads/report/report_pdf_file/aud-fm-27-01.pdf
LLNL Scientist Andrea L. Kritcher Earns E.O. Lawrence Award
LIVERMORE, California, Oct. 14 -- The U.S. Department of Energy Lawrence Livermore National Laboratory issued the following news:
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LLNL scientist Andrea L. Kritcher earns E.O. Lawrence Award
Lawrence Livermore National Laboratory (LLNL) scientist Andrea L. Kritcher was named one of nine recipients of the prestigious 2026 Ernest Orlando Lawrence Award for exceptional contributions in research and development supporting the U.S. Department of Energy's (DOE) missions in science, energy and national security.
She was recognized for "exceptional design efforts leading to the first-ever achievement
... Show Full Article
LIVERMORE, California, Oct. 14 -- The U.S. Department of Energy Lawrence Livermore National Laboratory issued the following news:
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LLNL scientist Andrea L. Kritcher earns E.O. Lawrence Award
Lawrence Livermore National Laboratory (LLNL) scientist Andrea L. Kritcher was named one of nine recipients of the prestigious 2026 Ernest Orlando Lawrence Award for exceptional contributions in research and development supporting the U.S. Department of Energy's (DOE) missions in science, energy and national security.
She was recognized for "exceptional design efforts leading to the first-ever achievementof fusion ignition in the laboratory, which is of major scientific impact to institutional and national missions, the private sector and fusion interests within academia."
"This year's Lawrence Award recipients exemplify the ingenuity and determination that drive America's leadership in science and technology," said U.S. Secretary of Energy Chris Wright. "From achieving fusion ignition to advancing critical materials and high-performance computing, these scientists and engineers are tackling some of our nation's most complex challenges and translating groundbreaking research into real-world capabilities. Their work strengthens our nation's energy security, drives American innovation and ensures the United States remains at the forefront of scientific discovery."
"I was pleasantly surprised and deeply humbled to learn I am receiving the E.O. Lawrence Award. My 22-year journey at Lawrence Livermore has been a wild ride at an extraordinary, unmatched place for science," Kritcher said. "Achieving fusion ignition was a monumental goal that generations of scientists and engineers worked toward. I feel incredibly fortunate to have had the opportunity to play a significant role in achieving this milestone."
She began her LLNL career in 2004 as a summer intern while studying nuclear engineering at the University of Michigan, returning as a Lawrence Graduate Scholar while earning her Ph.D. at the University of California, Berkeley and later earning the prestigious Lawrence Postdoctoral Fellowship. Over more than 22 years at the Laboratory, she has worked across nuclear physics, high-energy-density physics and inertial-confinement fusion experiment and design.
Kritcher developed and led the physics design of a series of landmark National Ignition Facility (NIF) fusion experiments, including the first burning fusion plasma in 2021, experiments that satisfied Lawson's criterion for ignition later that year, and the December 2022 experiment that achieved fusion ignition and target gain greater than one for the first time in any laboratory fusion experiment. She has continued to lead design and development of the ignition platform through subsequent experiments that have achieved progressively higher fusion performance.
In 2022, she received the John Dawson Award in plasma physics. Kritcher became an American Physical Society Fellow in 2023 and was named to the "Time 100" (one of Time magazine's 100 most influential people in the world in 2023) and Nature's top 10 list (one of 10 people who made the most significant contributions to science).
Currently she serves as a leader in the Inertial Confinement Fusion program at LLNL and leads efforts to develop the next generation of higher-yield NIF designs, building on the experimentally demonstrated NIF ignition platform to further increase fusion performance and yield.
Established in 1959, the Lawrence Award recognizes mid-career U.S. scientists and engineers who have advanced new research and scientific discovery in nine categories representing the broad science and engineering missions of DOE and its programs. The awards are among the longest-running and most prestigious science and technology awards bestowed by the U.S. government.
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Original text here: https://www.llnl.gov/article/55116/llnl-scientist-andrea-l-kritcher-earns-eo-lawrence-award
Ginnie Mae Mortgage-Backed Securities Portfolio Reached $3.03 Trillion in September
WASHINGTON, Oct. 14 -- Ginnie Mae issued the following news release:
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Ginnie Mae Mortgage-Backed Securities Portfolio Reached $3.03 Trillion in September
10/13/2026
Washington, D.C. - Ginnie Mae's mortgage-backed securities (MBS) portfolio outstanding grew to $3.03 trillion as of September 2026. In addition, Ginnie Mae issued $46.52 billion in total MBS, resulting in net portfolio growth of $20.92 billion. Ginnie Mae facilitated the pooling and securitization of 62,891 first-time homebuyer loans year to date.
Key highlights from the September issuance include:
* $44.39 billion in Ginnie
... Show Full Article
WASHINGTON, Oct. 14 -- Ginnie Mae issued the following news release:
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Ginnie Mae Mortgage-Backed Securities Portfolio Reached $3.03 Trillion in September
10/13/2026
Washington, D.C. - Ginnie Mae's mortgage-backed securities (MBS) portfolio outstanding grew to $3.03 trillion as of September 2026. In addition, Ginnie Mae issued $46.52 billion in total MBS, resulting in net portfolio growth of $20.92 billion. Ginnie Mae facilitated the pooling and securitization of 62,891 first-time homebuyer loans year to date.
Key highlights from the September issuance include:
* $44.39 billion in GinnieMae II MBS.
* $2.12 billion in Ginnie Mae I MBS, including $2.09 billion for multifamily housing loans.
* The pooling and securitization of loans for more than 134,091 American households, including 62,891 first-time homebuyers.
For detailed information on monthly MBS issuance, unpaid principal balance, Real Estate Mortgage Investment Conduit issuance, and a broader analysis of global market trends, visit Ginnie Mae Disclosure.
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About Ginnie Mae
Ginnie Mae is a wholly government-owned corporation that attracts global capital into the housing finance system to support homeownership for veterans and millions of homeowners throughout the country. Ginnie Mae MBS programs directly support housing finance programs administered by the Federal Housing Administration, the U.S. Department of Veterans Affairs, the U.S. Department of Housing and Urban Development's Office of Public and Indian Housing, and the U.S. Department of Agriculture's Rural Housing Service. Ginnie Mae is the only MBS to carry the explicit full faith and credit of the U.S. Government. Additional information about Ginnie Mae is available at www.ginniemae.gov and on X, YouTube, Facebook, and LinkedIn.
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Original text here: https://www.ginniemae.gov/newsroom/press-release/ginnie-mae-mortgage-backed-securities-portfolio-reached-303-trillion
GSA IG: 'GSA Is Not Fully Complying With the Geospatial Data Act of 2018'
WASHINGTON, Oct. 14 (TNSrep) -- The General Services Administration Inspector General issued the following audit report entitled "GSA Is Not Fully Complying with the Geospatial Data Act of 2018."
Here are excerpts:
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Why We Performed This Audit
We performed this audit because the Geospatial Data Act of 2018 (GDA), Section 759(c), Audits, requires the inspector general of each covered agency to conduct an audit, not less than once every 2 years, of the covered agency's compliance with the GDA. Our audit objective was to assess GSA's fulfillment of its responsibilities under the GDA. Specifically,
... Show Full Article
WASHINGTON, Oct. 14 (TNSrep) -- The General Services Administration Inspector General issued the following audit report entitled "GSA Is Not Fully Complying with the Geospatial Data Act of 2018."
Here are excerpts:
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Why We Performed This Audit
We performed this audit because the Geospatial Data Act of 2018 (GDA), Section 759(c), Audits, requires the inspector general of each covered agency to conduct an audit, not less than once every 2 years, of the covered agency's compliance with the GDA. Our audit objective was to assess GSA's fulfillment of its responsibilities under the GDA. Specifically,we assessed GSA's compliance with the 13 requirements listed in GDA Section 759(a), Covered Agency Responsibilities.
What We Found
GSA is not fully complying with the GDA. We found that GSA is not meeting GDA requirements to:
* Maintain geospatial data;
* Maintain a geospatial data strategy;
* Maintain an inventory of all geospatial data assets; and
* Search for existing geospatial data before procuring new data.
These deficiencies, some of which are recurring, demonstrate that GSA is not managing its GDA responsibilities effectively.
What We Recommend
We recommend GSA's Chief Information Officer:
1. Ensure that the Inventory of Owned and Leased Properties (IOLP) and Federal Real Property Profile (FRPP) datasets contain accurate latitude and longitude coordinates based on each property's physical location except for those properties with a clear exemption for national security by taking the following actions:
* Conduct a cost-benefit analysis to identify cost-effective and feasible corrective actions to improve data accuracy.
* Based on the results of this analysis, implement the identified corrective actions to improve the accuracy of latitude and longitude coordinates in the IOLP and FRPP datasets.
* Describe any remaining data limitations in the IOLP and FRPP datasets' supporting documentation.
2. Establish a process to identify and correct discrepancies in the IOLP's Congressional District Representative Name data.
3. Update GSA's geospatial data strategy to align with the Federal Geographic Data Committee's Building the Geospatial Future Together - The National Spatial Data Infrastructure Strategic Plan 2025-2035.
4. Update The General Services Administration's GEOSPATIAL DATA Standard Operating Procedure (SOP) and Standards Guide, Version 2.2, to:
* Establish a process for maintaining GSA's geospatial data strategy and geospatial data inventory, including defining roles and responsibilities.
* Require formal documentation of each search performed before procuring new data, including the data sources checked and the results.
* Assign clear roles and responsibilities for performing the required search for existing geospatial data before procuring new data.
5. Establish processes to ensure Agency-wide compliance with the GDA, including clear roles and reporting responsibilities among the Geographic Information Systems Center of Excellence, the Data Evidence Governance Board, and the Chief Data Officer.
GSA's Chief Information Officer agreed with our recommendations. GSA's comments are included in their entirety in Appendix C.
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The report is posted at: https://www.gsaig.gov/sites/default/files/audit-reports/A260022%20Final%20Report%20-%20GSA%20Is%20Not%20Fully%20Complying%20with%20the%20Geospatial%20Data%20Act%20of%202018.pdf
Federal Reserve Bank of New York: Statement Regarding Repurchase Agreement Small Value Exercise
NEW YORK, Oct. 14 -- The Federal Reserve Bank of New York issued the following statement:
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Statement Regarding Repurchase Agreement Small Value Exercise
October 13, 2026
The Open Market Trading Desk (the Desk) at the New York Fed undertakes small value open market transactions for the purpose of testing operational readiness to implement existing and potential policy directives from the Federal Open Market Committee (FOMC). The FOMC directs the Desk to conduct these exercises to test its operational readiness in the Authorizations and Continuing Directives for Open Market Operations.
In
... Show Full Article
NEW YORK, Oct. 14 -- The Federal Reserve Bank of New York issued the following statement:
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Statement Regarding Repurchase Agreement Small Value Exercise
October 13, 2026
The Open Market Trading Desk (the Desk) at the New York Fed undertakes small value open market transactions for the purpose of testing operational readiness to implement existing and potential policy directives from the Federal Open Market Committee (FOMC). The FOMC directs the Desk to conduct these exercises to test its operational readiness in the Authorizations and Continuing Directives for Open Market Operations.
Inconnection with these directives, the Desk intends to conduct a small value forward start term repo operation with Primary Dealers. The bid submission process will be conducted from 10:30 AM ET to 10:45 AM ET on Tuesday, October 20, 2026.
All counterparties will be limited to one $1 million proposition per tranche during the operation. Results will be posted on the New York Fed's website following the completion of the operation. The operation details are as follows:
Repurchase Agreement Operation:
OPERATION TENOR/TYPE ... ELIGIBLE COUNTERPARTIES ... OPERATION DATE ... SETTLEMENT DATE ... MATURITY DATE ... SECURITY TYPE ... MINIMUM BID RATE ... MAXIMUM VALUE OF OPERATION
Forward Start Overnight Repo ... Primary Dealers ... Tues Oct 20, 2026 ... Wed, Oct 21, 2026 ... Fri, Oct 23, 2026 ... Multi-tranche: Treasury, Agency, Agency MBS ... SRP Rate on Oct 20, 2026 ... $100 million
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Original text here: https://www.newyorkfed.org/markets/opolicy/operating_policy_261013
FDA Office of Inspections & Investigations Issues Warning Letter to Moda Food
WASHINGTON, Oct. 14 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Moda Food LLC from its Office of Inspections and Investigations:
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Recipient: Rubil Vural, Owner, Moda Food LLC, 4 Andrews Dr, Woodland Park, NJ 07424, United States
(b)(6), (b)(7)(C)
Issuing Office: Office of Inspections and Investigations, United States
WARNING LETTER
Re: CMS # 727800
Dear Mr. Rubil Vural,
On March 13 through 18, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of
... Show Full Article
WASHINGTON, Oct. 14 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Moda Food LLC from its Office of Inspections and Investigations:
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Recipient: Rubil Vural, Owner, Moda Food LLC, 4 Andrews Dr, Woodland Park, NJ 07424, United States
(b)(6), (b)(7)(C)
Issuing Office: Office of Inspections and Investigations, United States
WARNING LETTER
Re: CMS # 727800
Dear Mr. Rubil Vural,
On March 13 through 18, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection ofModa Food LLC, located at 4 Andrews Dr, Woodland Park, NJ 07424. We also conducted inspections on December 29, 2022, December 6, 2023, and June 12, 2024. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA's FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods from the foreign suppliers indicated in the attached list, as well as your Phyllo imported from (b)(4), your Baklava (Double Pistachio) imported from (b)(4), and your Tahini Halva imported from (b)(4), all located in (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations. We have not received your response to the Form FDA 483a issued on March 18, 2026.
Your significant violations of the FSVP regulation are as follows:
1. You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, you did not develop an FSVP for the foods you import from the foreign suppliers indicated in the attached list.
During the inspection, you stated that the foods for which you had no FSVPs were samples for food shows and for research and development. Pursuant to 21 CFR 1.501(c), food imported for research or evaluation is exempt from the FSVP requirements provided that it is: (1) not intended for retail sale and is not sold or distributed to the public, (2) labeled with the statement "Food for research or evaluation use," (3) imported in a small quantity that is consistent with a research, analysis, or quality assurance purpose, the food is used only for this purpose, and any unused quantity is properly disposed of, and (4) accompanied, when filing entry with U.S. Customs and Border Protection, by an electronic declaration that the food will be used for research or evaluation purposes and will not be sold or distributed to the public. You did not provide any documentation for any of these imported products that demonstrated that they met any of the criteria for an exemption for food imported for research or evaluation under 21 CFR 1.501(c). We note that, based on information available to FDA, some of the foods were not imported in a small quantity that is consistent with a research, analysis, or quality assurance purpose (see 21 CFR 1.501(c)(3)).
2. You did not meet the requirements to perform foreign supplier verification activities as required by 21 CFR 1.506. Specifically, for your Phyllo imported by (b)(4), Baklava (Double Pistachio) imported by (b)(4), and your Tahini Halva imported by (b)(4), you did not determine and document which verification activity or activities, as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the foods you obtain from these foreign suppliers are produced in accordance with 21 CFR 1.506(c), as required by 1.506(d). Furthermore, you did not document or obtain documentation of one or more supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv) for each of these foreign suppliers before importing the foods and periodically thereafter, as required by 21 CFR 1.506(e)(1).
Your FSVPs for the foreign suppliers referenced above state that your supplier verifications are conducted through a combination of "documentation review" and "supplier approval procedures". Each FSVP says that the foreign supplier maintains certifications and lists the certification standard(s), indicating that these certifications either confirm or verify that the supplier maintains a "food safety management system." Additionally, you told our investigator during the inspection that your verification activities consist of (b)(4), (b)(3)(A) status. However, as noted above, you did not determine and document the frequency of these activities, as required by 21 CFR 1.506(d). Furthermore, you were unable to provide any documents that you reviewed as part of your supplier verification activities (e.g., certificates, audit reports), or any documentation of your review and assessment of any records of supplier verification activities, as required by 1.506(e)(1). We note that if you conduct a review of the foreign supplier's relevant food safety records as a foreign supplier verification activity, you must retain documentation of each record review, including the date(s) of review, the general nature of the records reviewed, the conclusions of the review, any corrective actions taken in response to significant deficiencies identified during the review, and documentation that the review was conducted by a qualified individual, as required by 21 CFR 1.506(e)(1)(iii).
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.
This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place the foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert # 99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations. You should include in your response documentation and information that would assist us in evaluating your corrections (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: Tara Carmody, Compliance Officer, Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) Tara.Carmody@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Carmody via email at Tara.Carmody@fda.hhs.gov. Please reference CMS # 727800 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Sincerely,
/S/ CDR Joseph S. Tomao, Program Division Director, Division of Northeast Imports
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/moda-food-llc-727800-09092026
FDA Center for Veterinary Medicine Issues Warning Letter to Lewis Sausage
WASHINGTON, Oct. 14 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Lewis Sausage Co. Inc. from its Center for Veterinary Medicine:
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Recipient: Donald Myers, General Manager/Owner, Lewis Sausage Company Inc., 1050 Old Savannah Road, Burgaw, NC 28225-0280, United States, dmyers@lewissausage.com
Issuing Office: Center for Veterinary Medicine, United States
WARNING LETTER
CMS # 717432
Dear Donald Myers:
The U.S. Food and Drug Administration (FDA) and North Carolina Department of Agriculture and Consumer Services (NCDACS)
... Show Full Article
WASHINGTON, Oct. 14 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Lewis Sausage Co. Inc. from its Center for Veterinary Medicine:
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Recipient: Donald Myers, General Manager/Owner, Lewis Sausage Company Inc., 1050 Old Savannah Road, Burgaw, NC 28225-0280, United States, dmyers@lewissausage.com
Issuing Office: Center for Veterinary Medicine, United States
WARNING LETTER
CMS # 717432
Dear Donald Myers:
The U.S. Food and Drug Administration (FDA) and North Carolina Department of Agriculture and Consumer Services (NCDACS)conducted a joint inspection of your pet food manufacturing facility, located at 1050 Old Savannah Road, Burgaw, North Carolina, from August 25 through August 29, 2025, as a follow-up to an Untitled Letter issued to your facility on March 14, 2025. We also received and evaluated your written responses to the Form FDA 483, Inspectional Observations (FDA 483), dated September 22, 2025, and March 19, 2026.
During the inspection, the investigators found evidence of significant violations of FDA's Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements, Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507), which cause your products to be adulterated in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health.1 The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act.2 Also, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive control requirements of 21 CFR Part 507 (located in subparts A, C, D, E, and F of Part 507) is a prohibited act.3
On August 11, 2025, NCDACS, in cooperation with FDA, conducted sampling of (b)(4) Chicken Dog Food, lot (b)(4), (b)(4) Pet Food Mixer, lot (b)(4), and (b)(4) Turkey & Beef Puppy Food, lot (b)(4), which you contract manufacture. The unopened samples were collected from a third-party wholesale distributor. Sample analysis revealed the finished products contained Salmonella or Listeria monocytogenes, as described below. Therefore, your (b)(4) Chicken Dog Food, lot (b)(4), (b)(4) Chicken Pet Food Mixer, lot (b)(4), and (b)(4) Turkey & Beef Puppy Food, lot (b)(4), are adulterated in that they bear or contain a poisonous or deleterious substance which may render them injurious to health.4 These pathogen-positive samples led to (b)(4).
This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that we found during our inspection of your operation. You may find the FD&C Act and FDA's regulations through links on FDA's homepage at www.fda.gov.
At the close of the inspection, you were issued an FDA 483. As noted above, we received your response dated September 22, 2025, and March 19, 2026. We have reviewed your response, and we discuss your proposed corrections below in relation to each of the noted violations.
Hazard Analysis and Risk-Based Preventive Controls Requirements
Your animal food facility is subject to the Hazard Analysis and Risk-Based Preventive Controls requirements found in 21 CFR part 507, subparts A, C, D, E, and F. During our inspection of your facility, the investigators observed evidence of significant violations of these requirements, including the following:
1. You did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control are significantly minimized or prevented and the animal food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the FD&C Act, as required by 21 CFR 507.34(a)(1).
Your hazard analysis, titled "(b)(4)," dated July 28, 2025, identified biological hazards including Salmonella, L. monocytogenes, and Escherichia coli O157:H7 as hazards requiring a preventive control at the "(b)(4)" manufacturing step. Your food safety plan identified one process preventive control which includes applying (b)(4) to control pathogen hazards. However, your (b)(4) preventive controls are not adequate, as shown by the following samples5 of three finished products that were collected after implementation of your preventive control and found to contain Salmonella or L. monocytogenes:
* Sample (b)(4) Chicken Pet Food Mixer, lot (b)(4), was found to contain Salmonella Enteritidis.
* Sample (b)(4) Chicken Dog Food, lot (b)(4), was found to contain Salmonella Enteritidis.
* Sample (b)(4) Turkey & Beef Puppy Food, lot (b)(4), was found to contain L. monocytogenes.
Additionally, your "(b)(4)" SOP (SOP-507.34-01) states to (b)(4)." You verbally stated during the inspection, the mixing time was (b)(4), which is not established in your written procedure. However, our investigators observed mixing times of 153, 142, and 75 seconds on August 27, 2025, during the production of turkey food for cats, lot (b)(4).
Evaluation of your response:
Your response dated September 22, 2025, included a corrective and preventive action report for the lots of pet food referenced above, an updated hazard analysis that includes an updated preventive control for pathogens, a new monitoring record for the updated preventive control, an updated (b)(4) Procedure, and an assessment of mixing times on (b)(4) distribution. However, your March 19, 2026, response indicates you have replaced (b)(4) in-process ingredients with (b)(4) of finished products in final packaging as a preventive control for biological hazards.
In your March 19, 2026, response, you also presented an updated food safety plan, "Finished Product Pathogen Testing Program" (SOP-507.49.01), and (b)(4) studies (b)(4) of your finished products. Your updated hazard analysis identifies that (b)(4) addresses biological hazards associated with your ingredients and process, and that you have contracted a third-party manufacturing facility to conduct the (b)(4) processing on finished products. However, we are unable to fully evaluate the adequacy of your corrective actions because you did not provide documentation supporting that this preventive control has been implemented for the finished products you manufacture.
2. You did not validate that the preventive controls you identified and implemented in accordance with 21 CFR 507.34 are adequate to control the hazard as appropriate to the nature of the preventive control and its role in your facility's food safety system, as required by 21 CFR 507.47(a).
Specifically, your firm added (b)(4) as a preventive control for pathogens in your pet food products in accordance with the "(b)(4)" SOP (SOP-507.34-01). You implemented this procedure based upon (b)(4) studies conducted by your third-party consulting laboratory regarding the use of (b)(4) in your pet food products. FDA's review of your validation studies using (b)(4) to control Salmonella and L. monocytogenes determined these studies do not support your claim that the probiotic is an effective preventive control. This is further demonstrated by the detection of Salmonella or L. monocytogenes in your finished pet food as described above.
Additionally, your validation studies did not address other pathogens you have determined to be hazards requiring a preventive control, such as E. coli O157:H7.
Evaluation of your response:
In your written response, dated September 22, 2025, you provided (b)(4) studies previously submitted to the FDA as well as supplemental information pertaining to the studies. However, your March 19, 2026, response indicated you have replaced the (b)(4) of in-process ingredients with (b)(4) of finished products in final packaging as a preventive control.
Additionally, in your written response, dated March 19, 2026, you presented (b)(4) validation studies for (b)(4). You evaluated the inactivation of Salmonella, L. monocytogenes, and Shiga toxin-producing Escherichia coli using continuous (b)(4) of pathogens. We have reviewed your validations and note the validation studies do not include determination of the pathogenic load for your product before undergoing (b)(4). Without knowing the typical starting pathogenic load for your product, we are unable to determine if the (b)(4) achieved by your (b)(4) validation studies is adequate to significantly minimize6 pathogens. We acknowledge that in Table (b)(4) of each study, you analyzed (b)(4) and (b)(4). However, (b)(4) is an indicator of the overall microbial population and does not directly measure the presence/absence of pathogenic microorganisms.
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that you comply with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address this matter may lead to regulatory action, or where appropriate, legal action.
For more information about FDA's current thinking on the requirements of 21 CFR Part 507, see:
* For Industry | FDA (https://www.fda.gov/animal-veterinary/resources-you/industry)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe your products are not in violation of the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.
The Food & Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance is encouraging electronic submission of any response you choose to submit to this letter. We encourage you to submit files up to 100 megabytes in a single email, and to divide files greater than 100 megabytes so they may be submitted as smaller files in separate emails. If you submit electronic correspondence, please ensure that your facility's name, the CMS number at the top of this letter, and the inspection location are included in your correspondence. We intend to issue an electronic acknowledgement upon receipt of your email.
Please direct your electronic correspondence to Compliance Officer Andrew J. Howard at Andrew.Howard@fda.hhs.gov. If you have questions regarding this letter, please contact Compliance Officer Andrew J. Howard by telephone at (410) 779-5125, or by email.
/S/ Isaac K. Carney, Director of Food Compliance, Office of Surveillance and Compliance, Center for Veterinary Medicine, U.S. Food and Drug Administration
Cc:
(b)(4)
(b)(6), (b)(7)(C)
North Carolina Department of Agriculture and Consumer Services
4400 Reedy Creek Road
Raleigh, NC 27607
(b)(6), (b)(7)(C)
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Footnotes:
1/ See Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. Sec. 342(a)(4)], and 21 CFR 507.1(a)(1)(ii).
2/ See Section 301(a) of the FD&C Act [21 U.S.C. Sec. 331(a)].
3/ See Section 301(uu) of the FD&C Act [21 U.S.C. Sec. 331(uu)].
4/ See Section 402(a)(1) of the FD&C Act [21 U.S.C. Sec. 342(a)(1)].
5/ Although NCDACS collected these samples, FDA reviewed and concurred with the NCDACS sample collection and analytical report packages.
6/ Significantly minimize means to reduce to an acceptable level, including to eliminate (21 CFR 507.3).
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lewis-sausage-company-inc-717432-08052026
