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Smithsonian's National Zoo and Conservation Biology Institute and Royal Commission for AlUla Advance Next Phase of Global Effort To Save the Critically Endangered Arabian Leopard
WASHINGTON, Feb. 11 -- The Smithsonian Institution National Zoo and Conservation Biology Institute issued the following news release:* * *
Smithsonian's National Zoo and Conservation Biology Institute and Royal Commission for AlUla Advance Next Phase of Global Effort To Save the Critically Endangered Arabian Leopard
With fewer than an estimated 120 Arabian leopards remaining in the wild, coordinated global action is essential to prevent the extinction of one of the world's rarest big cat species.
On Feb. 10, the International Day of the Arabian Leopard, the Smithsonian's National Zoo and Conservation ... Show Full Article WASHINGTON, Feb. 11 -- The Smithsonian Institution National Zoo and Conservation Biology Institute issued the following news release: * * * Smithsonian's National Zoo and Conservation Biology Institute and Royal Commission for AlUla Advance Next Phase of Global Effort To Save the Critically Endangered Arabian Leopard With fewer than an estimated 120 Arabian leopards remaining in the wild, coordinated global action is essential to prevent the extinction of one of the world's rarest big cat species. On Feb. 10, the International Day of the Arabian Leopard, the Smithsonian's National Zoo and ConservationBiology Institute (NZCBI) and the Royal Commission for AlUla (RCU) announced the next phase of their partnership to support the long-term recovery of the critically endangered species. The finalized gift agreement builds on a long-standing relationship with the Smithsonian that began in 2023 and a cooperative framework signed by NZCBI in May 2025. It formalizes broader collaboration across conservation science, animal care, research and public education.
RCU leads long-term Arabian leopard recovery efforts focused on habitat restoration, advanced breeding, genetic resilience and eventual rewilding across the species' native range. That work is expanded through collaboration with NZCBI, drawing on decades of experience supporting the recovery of more than 25 rare and endangered species worldwide.
"This partnership allows us to do what we do best--apply science to help bring a species back from the brink of extinction," said Brandie Smith, the John and Adrienne Mars Director of NZCBI. "Building on recovery efforts already underway, we're translating that science into action to help people understand what's at stake."
"As custodians of the Arabian leopard, our responsibility is not only to prevent extinction, but to build the scientific foundation needed for long-term recovery," said Naif Al Malik, vice president for wildlife and natural heritage at RCU. "That responsibility requires working with partners who bring deep conservation expertise and global reach. The Smithsonian strengthens our efforts through science, animal care and public engagement, helping ensure the Arabian leopard has a future that extends across generations."
Construction on a new Arabian leopard exhibit at the Zoo in Washington, D.C., is expected to begin in late summer 2026, with a public opening projected for 2029. The exhibit will be the first to showcase Arabian leopards outside the Arabian Peninsula, connecting millions of visitors to the science behind species recovery through free admission and a live webcam featuring the ambassador pair.
Designed to reflect the rugged landscapes and architectural heritage of the Arabian Peninsula, the exhibit will feature soft, curvilinear forms inspired by rocky outcrops, desert terrain and wadi-carved landforms. Indoor and outdoor viewing areas will immerse visitors in the leopard habitat while highlighting the science behind protecting the species and restoring the ecosystems it depends on.
The exhibit will be home to a pair of critically endangered Arabian leopards transferred from RCU's breeding facility to the Zoo under a 15-year agreement, with no loan or acquisition fee. Any cubs born at the Zoo will be transferred to Saudi Arabia at a time mutually agreed upon by NZCBI and RCU to support the broader species recovery and reintroduction effort. NZCBI and RCU will also conduct cooperative research projects in Washington, D.C., and Saudi Arabia focused on genetics, reproductive science, animal welfare and long-term population management.
The initiative is made possible through a $51.6 million gift from RCU, supporting exhibit construction, animal transport, conservation research, dedicated scientific staff and long-term recovery outcomes.
The Arabian leopard (Panthera pardus nimr) is classified as critically endangered by the International Union for Conservation of Nature. Once ranging widely across the Arabian Peninsula, the species has experienced dramatic declines due to habitat loss, hunting and prey depletion, underscoring the urgency of sustained, collaborative conservation efforts.
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About the Smithsonian's National Zoo and Conservation Biology Institute
The Smithsonian's National Zoo and Conservation Biology Institute (NZCBI) leads the Smithsonian's global effort to save species, better understand ecosystems and train future generations of conservationists. Its two campuses are home to some of the world's most critically endangered species. Always free of charge, the Zoo's 163-acre park in the heart of Washington, D.C., features 2,200 animals representing 400 species and is a popular destination for children and families. At the Conservation Biology Institute's 3,200-acre campus in Virginia, breeding and veterinary research on 264 animals representing 20 species provide critical data for the management of animals in human care and valuable insights for conservation of wild populations. NZCBI's more than 300 staff and scientists work in Washington, D.C., Virginia and with partners at field sites across the United States and in more than 30 countries to save wildlife, collaborate with communities and conserve native habitats. NZCBI is a long-standing accredited member of the Association of Zoos and Aquariums.
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About the Royal Commission for AlUla
Located 1,100 kilometers from Riyadh, in northwest Saudi Arabia, AlUla is a place of extraordinary natural and human heritage. The vast area, covering 22,561 square kilometers, includes a lush oasis valley, towering sandstone mountains and ancient cultural heritage sites dating back thousands of years to when the Lihyan and Nabataean kingdoms reigned.
The most well-known and recognized site in AlUla is Hegra, Saudi Arabia's first UNESCO World Heritage Site. A 52-hectare ancient city, Hegra was the principal southern city of the Nabataean Kingdom and is composed of over 140 well-preserved tombs, many with elaborate facades cut out of the sandstone outcrops surrounding the walled urban settlement.
Current research also suggests Hegra was the most southern outpost of the Roman Empire after the Romans conquered the Nabataeans in 106 C.E.
In addition to Hegra, AlUla is also home to ancient Dadan, the capital of the Dadan and Lihyan Kingdoms and considered to be one of the most developed first millennium B.C.E. cities of the Arabian Peninsula, and Jabal Ikmah, an open-air library of hundreds of inscriptions and writings in many different languages, which was recently listed on the UNESCO's Memory of the World Register. AlUla Old Town, a labyrinth of more than 900 mudbrick homes developed from at least the 12th century, was selected as one of the World's Best Tourism Villages in 2022 by the UNWTO.
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Original text here: https://www.si.edu/newsdesk/releases/smithsonians-national-zoo-and-conservation-biology-institute-and-royal-commission
SEC Dismisses Civil Enforcement Action Against Illinois Investment Adviser and Its Minority Owner and Simultaneously Institutes Settled Administrative Proceeding
WASHINGTON, Feb. 11 -- The Securities and Exchange Commission issued the following litigation release (No. 21-cv-3450; N.D. Ill. filed June 28, 2021):* * *
Securities and Exchange Commission v. Barrington Asset Management and Gregory D. Paris, No. 21-cv-3450 (N.D. Ill. filed June 28, 2021)
On February 10, 2026, the Securities and Exchange Commission filed a joint stipulation with Barrington Asset Management, Inc., an investment adviser located and registered in Illinois, and Gregory David Paris, a minority owner, vice president and chief compliance officer of Barrington, to dismiss, with prejudice, ... Show Full Article WASHINGTON, Feb. 11 -- The Securities and Exchange Commission issued the following litigation release (No. 21-cv-3450; N.D. Ill. filed June 28, 2021): * * * Securities and Exchange Commission v. Barrington Asset Management and Gregory D. Paris, No. 21-cv-3450 (N.D. Ill. filed June 28, 2021) On February 10, 2026, the Securities and Exchange Commission filed a joint stipulation with Barrington Asset Management, Inc., an investment adviser located and registered in Illinois, and Gregory David Paris, a minority owner, vice president and chief compliance officer of Barrington, to dismiss, with prejudice,the SEC's civil enforcement action against Barrington and Paris. Simultaneous with filing the joint stipulation, the SEC instituted a settled administrative proceeding against Barrington and Paris.
The SEC's investigation and litigation were conducted by Peter Senechalle, Jonathan S. Polish, BeLinda I. Mathie, and Craig L. McShane of the SEC's Chicago Regional Office, with the assistance of Frank A. Brown, II and Ross Goetz of the Division of Economic and Risk Analysis. The investigation was supervised by Amy Flaherty Hartman of the Chicago Regional Office and Joseph Sansone of the Enforcement Division's Market Abuse Unit.
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Resources
* Order Instituting Proceedings (https://www.sec.gov/files/litigation/admin/2026/34-104793.pdf)
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Original text here: https://www.sec.gov/enforcement-litigation/litigation-releases/lr-26480
NIH Halts Arm of Clinical Trial Evaluating a Potential Stroke Treatment
WASHINGTON, Feb. 11 (TNSrep) -- The U.S. Department of Health and Human Services' National Institutes of Health issued the following news release:* * *
NIH halts arm of clinical trial evaluating a potential stroke treatment
Study found low-dose rivaroxaban to be unsafe and ineffective compared to standard of care.
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The National Institutes of Health (NIH) has stopped an investigational treatment arm of the Comparison of Anti-coagulation and Anti-platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) study (https://clinicaltrials.gov/study/NCT05047172?term=CAPTIVA&rank=2), following ... Show Full Article WASHINGTON, Feb. 11 (TNSrep) -- The U.S. Department of Health and Human Services' National Institutes of Health issued the following news release: * * * NIH halts arm of clinical trial evaluating a potential stroke treatment Study found low-dose rivaroxaban to be unsafe and ineffective compared to standard of care. * The National Institutes of Health (NIH) has stopped an investigational treatment arm of the Comparison of Anti-coagulation and Anti-platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) study (https://clinicaltrials.gov/study/NCT05047172?term=CAPTIVA&rank=2), followinga regular review by the Data Safety and Monitoring Board (DSMB). The DSMB is an independent group of experts that regularly check if the study is safe. NIH's National Institute of Neurological Disorders and Stroke, the trial's funder, accepted the DSMB recommendation that CAPTIVA discontinue the low-dose rivaroxaban arm of the trial due to an increase in safety events and evidence of futility, a pre-specified stopping point to enable the study to end if early results showed the treatment is unlikely to help people. Rivaroxaban is a U.S. Food and Drug Administration-approved anticoagulant medication used to treat or prevent blood clots. All study sites that have active participants randomized to the discontinued arm have received instructions for drug discontinuation. Study participants who have completed their evaluation of the discontinued arm will be contacted by the site where they received treatment. Participant safety remains NIH's top priority.
The CAPTIVA study is a large, two-stage, double-blind randomized trial in participants age 30 and older with a stroke attributed to 70-99% narrowing, or stenosis, of a major intracranial artery. The study is testing whether either of two new treatments works better than the current treatment to prevent another stroke. The study, part of NIH's StrokeNet, is in the midst of enrolling and evaluating up to 1,683 volunteers at over 100 study sites over a four-year period. Participants were randomized 1:1:1 to one year of treatment with:
1. Ticagrelor (180 mg loading dose, then 90 mg twice daily) plus aspirin (81 mg daily)
2. Low-dose rivaroxaban (2.5 mg twice daily) plus aspirin (81 mg daily)
3. Clopidogrel (600 mg loading dose, then 75 mg daily) plus aspirin (81 mg daily)
In addition, participants will receive intensive risk factor management and lifestyle coaching. They will be evaluated at one month, four months, eight months, and one year after randomization into one of the study arms. At these intervals, participants will have their blood pressure checked, risk factors optimized and will be assessed for study outcomes.
CAPTIVA will not determine which new treatment is best. It will only show if either new treatment is better than what doctors currently use. Comparing the two new treatments directly would require many more patients. Nevertheless, CAPTIVA will provide important safety and efficacy data on both novel therapies.
The CAPTIVA Study and NIH's StrokeNet are funded by NIH's NINDS.
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About the National Institute of Neurological Disorders and Stroke (NINDS): NINDS is the nation's leading funder of research on the brain and nervous system. The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. https://www.ninds.nih.gov.
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About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NIH...Turning Discovery Into Health(R)
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Original text here: https://www.nih.gov/news-events/news-releases/nih-halts-arm-clinical-trial-evaluating-potential-stroke-treatment
FDA Issues Warning Letter to Signature Formulations
WASHINGTON, Feb. 11 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Signature Formulations LLC from the Center for Drug Evaluation and Research:* * *
Recipient: Ms. Maria Esparza, President and Owner, Signature Formulations, LLC, 5446 W Roosevelt St., Ste 101, Phoenix, AZ 85043, United States
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
Warning Letter 320-26-38
Dear Ms. Esparza:
The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Signature ... Show Full Article WASHINGTON, Feb. 11 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Signature Formulations LLC from the Center for Drug Evaluation and Research: * * * Recipient: Ms. Maria Esparza, President and Owner, Signature Formulations, LLC, 5446 W Roosevelt St., Ste 101, Phoenix, AZ 85043, United States Issuing Office: Center for Drug Evaluation and Research (CDER), United States Warning Letter 320-26-38 Dear Ms. Esparza: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, SignatureFormulations LLC., FEI 3011368010, at 5446 W Roosevelt St., Ste 101., Phoenix, from July 21 to 29, 2025.
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 August 29, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.
During our inspection, our investigators observed specific violations including, but not limited to, the following.
1. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(c)).
You manufacture (b)(4) over-the-counter (OTC) (b)(4) drug products and (b)(4) containing drug products in a shared facility, using multiple pieces of shared equipment. For example, (b)(4) was used to manufacture (b)(4) containing (b)(4) prior to manufacturing ORL kids bubblegum toothpaste. You manipulate and manufacture drugs with potent active ingredients without adequate facility separation to prevent cross-contamination of other drug products.
Your (b)(4) drug products contain (b)(4). Contamination of (b)(4) drug products with potent (b)(4) presents significant risk to patient safety.
In your response, you state that "exhaust systems or other systems to control contaminants are under study." However, our investigation identified use of non-dedicated equipment in a shared facility. Your response is inadequate because it does not address how you will ensure there are adequate facility and equipment controls to prevent cross contamination.
Contamination is generally nonuniformly distributed. Data obtained from retrospectively testing a small proportion of a batch (e.g., retain samples) is limited in its ability to retrospectively assess the extent of contamination in other portions of a batch. The lowest or highest results obtained from testing a small sample size is unlikely to reveal the true range of minimum and maximum contamination level that exists in a batch exposed to the contamination hazards identified at your firm. Consequently, the range of variability of contamination levels in batches produced by your firm remain characterized by substantial residual uncertainty. Because of the limitations of retrospective testing in gaining a representative understanding of the entire lot, testing retain samples alone is insufficient to determine the scope of the contamination issues and mitigate the associated risks. Further evaluation and scientific rationale is needed in your firm's risk assessment to reflect the nature of cross-contamination events and determine the degree of cross-contamination risk that may be posed to a portion of marketed batches.
On December 2, 2025, FDA held a teleconference with you recommending you consider removing any batches of ORL Kid's Natural Toothpaste and ORL Kid's mouthwash currently in distribution from the U.S. market.
On December 8, 2025, you issued a voluntarily recall of ORL kids bubblegum toothpaste lot number 250520P4-05/27 and ORL kids bubblegum mouthwash lot number 250505P9-05/27 due to potential contamination with exogenous hormones.
In response to this letter, provide:
* A comprehensive, independent assessment of the design and control of your firm's manufacturing operations with a detailed and thorough review of all (b)(4), and other active ingredient, cross-contamination hazards.
* Confirmation of whether you will discontinue manufacturing drugs on shared equipment in your facility and implement appropriate controls to prevent cross-contamination.
* Your plan to perform testing to identify (b)(4) contamination in all your drug products. Any testing performed to identify (b)(4) contamination should be scientifically sound, include appropriate sampling plans and test procedures, including methods that are appropriately validated, suitable for intended use, and sufficiently sensitive.
* A detailed risk assessment addressing the hazards posed by distributing drug products potentially contaminated with (b)(4). Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls.
* A summary of updated standard operating procedures (SOPs) that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.
2. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).
You failed to ensure your cleaning procedures are adequate to prevent cross-contamination of (b)(4) OTC drug products with the potent (b)(4) (e.g., (b)(4)). For example, you have inadequate cleaning validation for your non-dedicated manufacturing equipment.
In your response, you state that your cleaning and sanitization SOP has been updated and that dirty and damaged equipment components have been replaced. Cleaning to prevent cross contamination with potent ingredients on shared equipment is extremely difficult and unacceptable.
(b)(4) in (b)(4) OTC (b)(4) products pose a significant risk to public health. In children, exposure to even low levels of (b)(4) can lead to developmental and reproductive harm. Therefore, dedication of facilities and equipment should be considered.
In response to this letter, provide:
* A risk assessment for all drug products you have previously produced on shared equipment. For each product, assess the risk of potential contamination due to the shared equipment. Also, provide your plans for addressing the product quality and patient safety risks for any product still in distribution, including potential recalls or market withdrawals.
* 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 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 more than one product.
* A corrective action and preventive action (CAPA) plan based on the retrospective assessment of your cleaning and disinfection program. Include appropriate remediations to your cleaning and disinfection processes and practices and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning and disinfection. Describe improvements to your cleaning and disinfection program, including enhancements to cleaning effectiveness, improved ongoing verification of proper cleaning and disinfection execution for all products and equipment, and all other needed remediations.
* Evidence of the establishment of a cleaning validation program with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include, but not be limited to, identification and evaluation of all worst-case:
o Drugs with higher toxicities
o Drugs with higher drug potencies
o Drugs of lower solubility in their cleaning solvents
o Drugs with characteristics that make their residue difficult to clean
o Swabbing locations for areas that are most difficult to clean
o Maximum hold times before cleaning
* The steps that must be taken in your change management system before introduction of new manufacturing equipment or a new product.
* A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.
3. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).
You released finished drug products without adequate testing. For example, you did not perform adequate microbiological monitoring and chemical testing on your finished drug products. Further, you did not adequately validate the method you use for assay testing your bulk (b)(4) containing drug products.
Your response states that you do not "produce any products that are drugs." Your response is inadequate because your drug products are subject to CGMP requirements. Further, your response does not indicate that you will test your finished drug products to ensure they meet appropriate specifications.
Drug product batches must be tested for identity, strength, and purity prior to release. Testing is essential to ensure that the drug products you manufacture conform to all predetermined quality attributes appropriate for their intended use. Without adequate finished product release testing, you do not have scientific evidence that each batch of drug product conforms to appropriate specifications before release.
In your 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 chemical and microbial specifications, including test methods, used to analyze each batch of your drug products before a batch disposition decision.
* An action plan and timelines for conducting full chemical and microbiological testing of reserve samples to determine the quality of all batches of drug products distributed to the United States that are within expiry as of the date of this letter.
* A summary of all results obtained from testing reserve samples from each batch. If this testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.
4. Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)).
You lacked adequate quality unit (QU) oversight for the manufacture of your drug products. For example, your QU failed to ensure:
* Adequate testing of incoming raw materials, including performing identity testing of each shipment of each component (e.g. (b)(4)) used in the manufacture of your drug products (21 CFR 211.84(d)(2))
* Adequate laboratory controls and specifications (21 CFR 211.160(b))
* Adequate design and procedures for production and process controls for drug products and for maintenance and monitoring of your (b)(4) used to manufacture drug products (21 CFR 211.100(a))
* Adequate investigations into non-conformances (21 CFR 211.192)
* Establishment of a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a))
In your response, you again state that you do not manufacture any drug products. You further state that you updated your procedures to more clearly define the roles of the QU. Your response is inadequate because you do not address how you plan to ensure that your quality unit has sufficient resources to carry out its responsibilities and consistently ensure drug quality. You also do not address how you will maintain completeness and accuracy of the records used for batch release and other quality review decisions.
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 and laboratory 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.
See FDA's guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.
In your 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:
o A determination of whether procedures used by your firm are robust and appropriate
o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
o A complete and final review of each batch and its related information before the QU disposition decision
o 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.
Responsibilities as a Contractor
Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.
You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act for safety, identity, strength, quality, and purity. See FDA's guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.
Repeat Violations at Facility
In a previous warning letter CMS 545017, dated July 31, 2018, FDA cited similar CGMP violations. You proposed specific remediation for these violations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs are inadequate.
Drug Consultant Recommended
It is the responsibility of each person marketing and distributing drug products in the United States to comply with the requirements of the FD&C Act and its implementing regulations. Should you have questions concerning the laws and regulations for the products manufactured by your firm, including the products manufactured for contract customers, we recommend that you retain the services of a drug law consultant for assistance.
Because you failed to correct repeat violations, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA 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 violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also 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.
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 violations 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 3011368010 and ATTN: Zachary Bogorad.
Sincerely,
/S/ Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/signature-formulations-llc-718093-01212026
FDA Issues Warning Letter to Niqpouches.com
WASHINGTON, Feb. 11 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to niqpouches.com from the Center for Tobacco Products:* * *
Recipient: niqpouches.com, Sweden, info@niqpouches.com
Issuing Office: Center for Tobacco Products, United States
January 30, 2026
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://niqpouches.com and determined that nicotine pouch products listed there are offered for sale or distribution ... Show Full Article WASHINGTON, Feb. 11 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to niqpouches.com from the Center for Tobacco Products: * * * Recipient: niqpouches.com, Sweden, info@niqpouches.com Issuing Office: Center for Tobacco Products, United States January 30, 2026 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://niqpouches.com and determined that nicotine pouch products listed there are offered for sale or distributionto customers 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 intended for human consumption. Certain tobacco products, including nicotine pouch products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. Sec. 387a(b)) and 21 C.F.R. Sec. 1100.1, and are required to be in compliance with the requirements in the FD&C Act.
Please be aware that, on March 15, 2022, the President signed legislation to amend the FD&C Act to extend FDA's jurisdiction to products "containing nicotine from any source," not just nicotine derived from tobacco. See Consolidated Appropriations Act, 2022, Public Law 117-103, Division P, Title I, Subtitle B. Specifically, this legislation expanded the definition of "tobacco product" under section 201(rr) of the FD&C Act (21 U.S.C. Sec. 321(rr)) to include products containing nicotine from any source. Tobacco products, including nicotine pouch products, containing nicotine from any source, must be in compliance with the FD&C Act and its implementing regulations. For more information, please see https://www.fda.gov/tobacco-products/ctp-newsroom/requirements-products-made-non-tobacco-nicotine-take-effect-april-14.
Generally, to be legally marketed in the United States, the FD&C Act requires "new tobacco products" to have a premarket authorization order in effect. 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 (section 910(a) of the FD&C Act; 21 U.S.C. Sec. 387j(a)). Generally, a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. Sec. 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) the manufacturer of the product submitted a report under section 905(j) of the FD&C Act (21 U.S.C. Sec. 387e(j)) and FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) the manufacturer submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. Sec. 387e(j)(1)(A)(ii)) and all modifications are covered by exemptions from the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act (21 U.S.C. Sec. 387e(j)(3)).
New Tobacco Products Without Required Marketing Authorization Are Adulterated and Misbranded
FDA has determined that you offer for sale or distribution to customers in the United States nicotine pouch products that lack a marketing authorization order: On! PLUS Berry Regular, On! PLUS Berry Slim Strong, On! PLUS Watermelon Mint Regular, On! PLUS Watermelon Mint Strong, On! PLUS Citrus Regular, On! PLUS Citrus Strong, On! PLUS Raspberry Lemon Regular, On! PLUS Raspberry Lemon Strong, and On! PLUS Raspberry Lemon Extra Strong.
The tobacco products listed above are new tobacco products because they were not commercially marketed in the United States as of February 15, 2007. These products do not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt from the marketing authorization requirement. Therefore, these products are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. Sec. 387b(6)(A)). In addition, they are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. Sec. 387c(a)(6)) because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act (21 U.S.C. Sec. 387e(j)).
Conclusion and Requested Actions
FDA has determined that your firm markets new tobacco products in the United States that lack premarket authorization. All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA's discretion.
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.
It is your responsibility to ensure that all tobacco products you sell and/or distribute in the United States and all related labeling and/or advertising on any websites or other media (such as e-commerce, social networking, or search engine websites), and in any retail establishments in which you advertise, 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., or its implementing regulations relating to tobacco products including the tobacco regulations 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. However, this Warning Letter does not constitute "written notice" for purposes of section 303(f)(9)(B)(i)(II) of the FD&C Act. Please note that tobacco products offered for import into the United States that appear to be adulterated and/or misbranded may be detained or refused admission.
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should take prompt action to address any violations that are referenced above and take any necessary actions to bring these 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 these products into compliance, including the dates on which you discontinued the violative sale and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you believe that these 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, RW2602389, 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/ John E. Verbeten, Director, Office of Compliance and Enforcement, Center for Tobacco Products
VIA Electronic Mail
cc:
Privacy Inc. Customer 0171985187
niqpouches.com@contactprivacy.com
Tucows Domains Inc.
domainabuse@tucows.com
Shopify, Inc.
abuse@shopify.com
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/niqpouchescom-722530-01302026
FDA Issues Warning Letter to Maui Seafood
WASHINGTON, Feb. 11 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Maui Seafood LLC from the Human Foods Program:* * *
Recipient: Yong J. Chang, Owner, Maui Seafood LLC, 1741 S. Mojave Rd, Las Vegas, NV 89104-4503, United States, mauiseafoodlv@gmail.com
Issuing Office: Human Foods Program, United States
WARNING LETTER
Re: CMS Case # 715844
Dear Mr. Chang:
The United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) seafood processing facility, located at 1741 S. Mojave Rd, ... Show Full Article WASHINGTON, Feb. 11 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Maui Seafood LLC from the Human Foods Program: * * * Recipient: Yong J. Chang, Owner, Maui Seafood LLC, 1741 S. Mojave Rd, Las Vegas, NV 89104-4503, United States, mauiseafoodlv@gmail.com Issuing Office: Human Foods Program, United States WARNING LETTER Re: CMS Case # 715844 Dear Mr. Chang: The United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) seafood processing facility, located at 1741 S. Mojave Rd,Las Vegas, NV 89104-4503, from April 28 through May 16, 2025. During our inspection of your facility, the FDA investigators found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123. Additionally, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility.
Based on FDA's inspectional findings and the analytical results for samples collected from your production environment, we have determined your RTE whole, raw, refrigerated fishery products including tuna and salmon, are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. Sec. 342(a)(4) in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. Furthermore, in accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. Sec. 342(a)(4)]. You may find the Act, the seafood HACCP regulation, and the June 2022 Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.
At the conclusion of the inspection, FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations, listing the violations found at your facility. You provided responses to the inspection on May 16 and 28, 2025, describing corrective actions taken or planned by your firm. After reviewing the inspectional findings, analytical results, and the responses that your firm provided, we are issuing this letter to advise you of FDA's concerns and to provide detailed information describing the findings at your facility. We address your responses below.
Pathogen Findings
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment. Without proper controls, L. monocytogenes can proliferate in food processing facilities where it may contaminate food. Therefore, it is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to apply controls or take corrective actions as necessary to eradicate the organism. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening illness called listeriosis, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.
FDA investigators collected environmental samples from your processing facility on April 30, 2025. FDA analysis of the environmental sample 1278716 confirmed that (b)(4) of (b)(4) environmental swabs were positive for L. monocytogenes. The positive findings included (b)(4) swabs collected from food contact surfaces including in the processing room on the top right of the salmon cutting board on table #(b)(4) (sub #(b)(4)); sub #(b)(4) which was collected from the top middle of the cutting board on table #(b)(4), metal crevice of the cutting board, and handle of hose; and on the far right and left side of the strip curtains in the staging area (subs #(b)(4) and #(b)(4)) that were observed to come into direct contact with RTE yellowfin tuna. Additionally, L. monocytogenes was found on the inside of the (b)(4) and (b)(4) drain slots in the processing room (subs #(b)(4) and #(b)(4)), and the center of drain #(b)(4) in the staging area (sub #(b)(4)).
Whole genome sequencing (WGS) was conducted on the above referenced L. monocytogenes isolates. The WGS analysis revealed (b)(4) strain that consisted of the (b)(4) L. monocytogenes isolates that matched (b)(4) isolate from a "smoked salmon" sample, and (b)(4) clinical isolates from 2017 and 2018, indicating that this strain can cause illness. We advised you of the importance of these WGS results via a conference call on June 4, 2025.
The presence of L. monocytogenes in your facility is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food or minimize its presence on food-contact surfaces. Appropriate control of L. monocytogenes in a food processing environment requires knowledge of the unique characteristics of the organism and implementing the corresponding hygienic practices necessary to control this pathogen. Once it is established in a production area, personnel or equipment can facilitate the pathogen's movement and contamination of food-contact surfaces and finished product. It is essential to identify the harborage sites in the food processing plant and equipment where this organism is able to grow and survive and to take such corrective actions as are necessary to eradicate the organism. Our evaluation of your response to the FDA's L. monocytogenes findings is discussed later in this letter.
Additionally, FDA environmental sample 1278716 also detected Listeria innocua (L. innocua), a non- pathogenic Listeria species, in (b)(4) environmental swabs, including on food contact surfaces. The presence of Listeria species such as L. innocua suggests that conditions are suitable for survival and/or growth of L. monocytogenes, which, as noted above, has been found in your facility.
Seafood HACCP Violations (21 CFR Part 123)
Your significant deviations are as follows:
1. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice (CGMP) requirements under 21 CFR Part 117, subpart B that are appropriate to your plant and food products (21 CFR 123.11(b)). However, your firm did not monitor the following conditions and practices with sufficient frequency to ensure cGMP compliance:
A. You did not ensure all food contact surfaces, including utensils, were cleaned as necessary to protect against food contamination, as required by 21 CFR 117.35(d). This is related to the condition and cleanliness of food contact surfaces, including utensils, as required by 21 CFR 123.11(b)(2). Specifically:
i. On April 28 and 29, 2025, cutting boards #(b)(4)-#(b)(4), used in the production of RTE salmon, were heavily worn and grooved. The grooves were soiled with brown, gray, and black filth. The top right corner of the salmon cutting board on table #(b)(4) was found positive for L. monocytogenes (Sample 1278716, sub #(b)(4)). The corners of cutting boards #(b)(4) and #(b)(4) had an accumulation of brown and black filth which can be potential pathogen harborage areas.
ii. On April 28, 2025, the ice scoop handle had clear tape wrapped around the handle. This tape had an accumulation of filth in the seams of each wrap. This ice scoop is used to scoop ice which has direct contact with RTE, raw seafood products, including salmon.
B. You did not conduct all food manufacturing, processing, packing, and holding under conditions and controls necessary to minimize the potential growth of microorganisms, contamination of food, and deterioration of food, as required by 21 CFR 117.80(c)(2). This is related to the prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product, as required by 21 CFR 123.11(b)(3). Specifically:
i. On April 28, 2025, an employee removed the floor drain cover in Cooler (b)(4) to scoop fish bones, blood, debris, and fish scales and fins out of the drain with their gloved hand. The employee then touched the hose to rinse the drain. Thereafter, the employee exited Cooler (b)(4) entered into Cooler (b)(4) running their gloved hands along the plastic door curtains upon exiting. The employee then re-entered Cooler (b)(4) from Cooler (b)(4), through the plastic door curtains, and resumed cleaning the drain, without washing hands and changing gloves between these different tasks.
A second employee then used their bare hands to put the drain cover back, then moved between Cooler (b)(4) and Cooler (b)(4) while touching the curtains in both directions. Thereafter, they pushed the rack of tuna loins into Cooler (b)(4) without washing their hands.
ii. On April 29, 2025, an employee used their gloved hands to pick up and throw away fish trimming scraps from the floor where there was an accumulation of filthy water, fish pieces, and filth with the appearance of blood in the Staging Area. L. monocytogenes was found approximately (b)(4) feet from this area in the center of drain #(b)(4) (Sample 1278716, sub #(b)(4)). This employee then immediately picked up a whole RTE big eye tuna product from a cardboard box and carried it into the Processing Room for processing without washing their hands and changing gloves. The FDA investigator did not observe this employee change their gloves during the entire processing shift.
iii. On April 29, 2025, an employee picked up a plastic case band (which is strapped around the Styrofoam cases of fish to secure the lids) off the floor in the Processing Room. This plastic case band was approximately (b)(4) from the drain that tested positive for L. monocytogenes (Sample 1278716, sub #(b)(4)). This employee then threw the plastic case band away and proceeded to descale RTE fresh salmon products without washing their hands and changing gloves. The salmon were processed on Table #1 which was positive for L. monocytogenes (Sample 1278716, sub #(b)(4)).
iv. On April 29-30, 2025, white cloth towels with a diluted bleach solution were used to wipe down cutting board #4 and then used to wipe down RTE fresh salmon products. The same towels were also used to wipe down finished product polystyrene boxes, creating cross-contamination between RTE products, food contact surfaces, and packaging materials. These towels were saturated by dipping them into a bleach solution of (b)(4)ppm contained in a red bucket on the bottom level of table #(b)(4). The bleach solution was not changed during processing, and by the end of processing, the solution in the red bucket had become opaque and gray. As the towels became dirty, turning from white to gray, they were not replaced with clean towels as needed. Additionally, after reviewing the bleach solution label, there are no indications that this bleach is safe, in any dilution, for use directly on food.
v. On April 28, 2025, seven seafood processing aprons were observed to be heavily soiled, including some stored outside the facility. The aprons were not cleaned and sanitized before the next processing shift on April 29, 2025, as (b)(4) of the (b)(4) soiled aprons were used by employees during processing without being cleaned before use. RTE yellowfin tuna, RTE big eye tuna, and RTE fresh salmon products came into direct contact with these (b)(4) soiled aprons during processing.
vi. On April 29, 2025, fresh, unpackaged RTE yellowfin tuna and RTE big eye tuna products passed through and were in direct contact of soiled curtains into the Processing Room, which was previously touched by two employees who touched the ground without washing hands and changing gloves. L. monocytogenes was found on curtains in the staging area leading into the Processing Room (Sample 1278716, subs #(b)(4) and #(b)(4)).
vii. On April 29-30, 2025, boxes and lids used for packing RTE salmon were stored directly on the floor in the Staging Area, which was observed flooded with dirty water and located near a drain that tested positive for L. monocytogenes (Sample 1278716, sub #68). These polystyrene boxes and lids were rinsed off with water from a hose, then carried through the soiled Processing Room curtains, which tested positive for L. monocytogenes (Sample 1278716, subs #(b)(4) and #(b)(4)), and then used to pack RTE fresh salmon products without any additional cleaning and sanitizing.
viii. On April 28-30, 2025, the walls and ceilings of the Processing Room and condenser unit #3 had an accumulation of black, gray, and brown filth, including material with the appearance of dried fish residue and mold, in areas where RTE seafood products are processed directly beneath and exposed to the environment.
C. You did not prevent drip condensate from fixtures, ducts and pipes from contaminating food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 117.20(b)(4). This is related to the protection of food, food packaging material, and food contact surfaces from adulteration with condensate, as required by 21 CFR 123.11(b)(5). Specifically:
i. On April 29 and 30, 2025, condensation from condenser unit #(b)(4) in Cooler (b)(4) was dripping onto boxes of RTE seafood products, including RTE fresh salmon product cases. Additionally, condensation was dripping directly onto RTE yellowfin tuna loins that were wrapped in plastic and stored on a four-level metal rack that was transported from Cooler (b)(4) into Cooler (b)(4). Additionally, on April 30, 2025, while the same four-level metal rack was staged below the condenser, condensation was dripping onto the rack and in direct contact with partially wrapped RTE yellowfin tuna loins.
ii. On April 28 and 30, 2025, condenser unit #(b)(4) was dripping onto additional RTE seafood product boxes in Cooler (b)(4). On April 29, 2025, there was accumulated condensation on top of a box of RTE yellowfin tuna product. When the box was moved from Cooler (b)(4) to the Staging Area, an employee opened the box lid and the pooled condensate water on the lid splashed onto another box of exposed RTE yellowfin tuna. Furthermore, on April 28, 2025, condenser unit #(b)(4) had a broken and leaking outflow pipe located approximately (b)(4) feet from boxes of RTE seafood products, which was dripping onto the wall and floor of Cooler (b)(4)
You explained to the FDA investigator that the condensers in Cooler (b)(4) had been dripping for approximately (b)(4) months. You indicated that you had been waiting for parts for the condenser units.
Additionally, your sanitation monitoring records do not accurately reflect the conditions in the facility as evidenced by your "Sanitation Standard Operating Procedures (SSOP) Monitoring Record" for "GENERAL SANITATION - Daily," between April 28-30, 2025, where the conditions described above were marked with an "s" for being satisfactory.
2. You must implement the monitoring procedures and frequency that you have listed in your HACCP Plan, to comply with 21 CFR 123.6(b) and (c)(4). Specifically:
A. For your HACCP Plan, "(b)(4)," revised October 20, 2023, for yellowfin tuna and big eye tuna products:
i. Your firm did not follow the monitoring procedures for "(b)(4) CCP #(b)(4)" which includes visual observation of adequacy of ice or gel packs present, verifying the internal temperature of one fish in (b)(4)% of shipping containers but not fewer than (b)(4) containers (or all containers if lot has less than (b)(4) containers) received, and digital time and temperatures of data loggers for transit periods over (b)(4) hours to control Scombrotoxin Formation and Pathogen Growth. Your "(b)(4)" logs do not show you are recording the adequacy of ice or gel packs for "Scombroid Species" and are only recording the internal temperature of one fish per shipment. Furthermore, you are not documenting a representative number of containers that were inspected. Your firm did not complete the "(b)(4)" for "Yellowfin Tuna" received on April 28, 2025, and processed on April 29, 2025. Also, adequate data logger records are not maintained to show your seafood products were continuously monitored during transits over (b)(4) hours.
ii. Your firm did not follow the monitoring procedures for "(b)(4)" of daily cooler temperature checks on normal working days and daily review of data logger at the next day of business for the time no one was at the facility. Your firm did not record temperatures for "Cooler (b)(4)" or meeting of critical limit for "(b)(4)" on your "(b)(4)" reviewed for December 30, 2024, through April 29, 2025. The "(b)(4)" had already been completed for April 30, 2025, through May 3, 2025, which were collected by FDA on April 29, 2025. Additionally, your HACCP Plan does not include a daily check of your data logger to ensure the storage temperature did not exceed (b)(4) F, as stated in your critical limit.
B. For your HACCP plan, "(b)(4)," revised January 6, 2025, for fresh salmon products:
i. Your firm did not follow the monitoring procedures for "(b)(4)" which includes verifying the internal temperature of one fish in (b)(4)% of shipping containers but not fewer than (b)(4) containers (or all containers if lot has less than (b)(4) containers) received and digital time and temperatures of data loggers for transit periods over (b)(4) hours to control Pathogen Growth and toxin formation. Your "(b)(4)" logs show you are only recording the internal temperature of (b)(4) fish per shipment and are not documenting a representative number of containers that were inspected. Also, adequate data logger records are not maintained to show your seafood products were continuously monitored during transit periods over (b)(4) hours.
ii. Your firm did not follow the monitoring procedures for "(b)(4)" of daily cooler temperature checks on normal working days and "(b)(4)." Your firm did not record temperatures for "Cooler (b)(4)" on your "(b)(4)" reviewed for December 30, 2024, through April 29, 2025. The "(b)(4)" had already been completed for April 30, 2025, through May 3, 2025, which were collected by FDA on April 29, 2025. Additionally, your HACCP Plan does not include a daily check of your data logger to ensure the storage temperature did not exceed (b)(4) F, as stated in the critical limit.
Additionally, you stated that your firm uses the "(b)(4)" to monitor fish temperature and processing room temperatures during processing of your fish products. For instance, your HACCP Plan for "(b)(4)", "(b)(4)" step, "(b)(4)", indicates your "(b)(4)" will be used to monitor "(b)(4)." You did not complete the "(b)(4)" form during the processing of your fish products on April 23-26, 2025.
3. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plan for "(b)(4)," revised January 7, 2025, lists a critical limit of (b)(4) F, which, at the "(b)(4)" and "(b)(4)" critical control points, is not adequate to control Clostridium botulinum growth and toxin formation. Your HACCP plan states (b)(4). Your receiving and finished product storage critical limits should ensure that these products are maintained below 38 F (3.3 C) throughout transit and stored below 38 F (3.3 C).
4. You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, and the plan is being effectively implemented. However, your firm did not review consumer complaints to determine whether they relate to the performance of critical control points or reveal the existence of unidentified critical control points to comply with 21 CFR 123.8(a)(2)(i). Additionally, when a deviation occurs, you are to ensure no product enters commerce that is either injurious to health or is otherwise adulterated and correct the cause of the deviation to comply with 21 CFR 123.7(b). During the inspection, you explained your "(b)(4)" log is also your log of complaints. During a review of your "(b)(4)" log, it was observed that between January 2, 2025 and April 29, 2025, you documented (b)(4) consumer complaints about your fish products which included (b)(4) complaints for tuna with returns related to bad quality, color changes, and brown color, but you did not document any corrective actions such as a food safety evaluation or the disposition of the product. Further, you explained that some products may be re-sold. For example, the complaints about your tuna indicate (b)(4).
We evaluated your May 16 and 28, 2025 responses, which included a repair estimate, and you explained that you (b)(4). You also stated that you (b)(4)." You further explained that on May 22, 2025, you were (b)(4)."
We acknowledge that after Southern Nevada Health District (SNHD) issued a cease-and-desist order on May 16, 2025, they conducted a follow-up inspection on May 22, 2025. According to the SNHD report, your facility made major construction repairs, and you conducted Listeria swabbing on all cutting boards, all prep tables, processing room wall, hand wash sink, 3-compartment sink, processing room drains and electrical switches, and warehouse areas including curtains and storage shelves. The report indicated that all test results were negative. As a result of their inspection, SNHD approved your facility to reopen.
While we acknowledge you were approved to reopen your facility by SNHD, based on the information you have provided, FDA is unable to evaluate if you are adequately controlling L. monocytogenes and if you are monitoring the sanitary conditions and practices in your facility. We continue to be concerned about your ability to maintain a sanitary environment, as you did not provide supporting documentation to demonstrate how you plan to prevent future reoccurrence of Listeria contamination including L. monocytogenes, and how you will ensure a sanitary environment is maintained. We recommend you consider taking additional actions, such as developing an environmental monitoring procedure, root cause analysis to determine the cause(s) of the Listeria findings and providing analytical results for environmental sample testing. We also recommend that you provide us with a copy of records of the cleaning and sanitizing of the facility with details on the procedures used (including the chemicals and method used, by whom, and when), a new cleaning and sanitizing procedure, standard sanitation operating procedures (SSOPs) and monitoring logs to demonstrate implementation of the SSOPs, and employee training records. Additionally, your response did not include a revised HACCP plan and critical control point monitoring records.
The violations cited in this letter are not intended to be an all-inclusive list of the violations that 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 your firm complies with all requirements of federal law, including applicable FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify FDA in writing within fifteen (15) working days of receipt of this letter, of the specific steps and corrections you have taken to address 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 do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Sheena Phillips, Compliance Officer, via email at Sheena.Phillips@fda.hhs.gov.If you have any questions regarding this letter, you may contact Sheena Phillips, Compliance Officer, via email at Sheena.Phillips@fda.hhs.gov. Please reference CMS # 715844 on any submissions and within the subject line of any email correspondence to the agency.
Sincerely,
/S/ Maria S. Knirk, JD, MBA, Acting Director, Office of Enforcement, Office of Compliance and Enforcement, Human Foods Program, Food and Drug Administration
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/maui-seafood-llc-715844-12102025
FDA Issues Warning Letter to Louisville Reproductive Center
WASHINGTON, Feb. 11 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Louisville Reproductive Center from the Center for Biologics Evaluation and Research:* * *
Recipient: Dr. Miriam S. Krause, Medical Director, Louisville Reproductive Center, 4123 Dutchmans Lane, Suite 416, Louisville, KY 40207-4733, United States, Mkrause@ivfkentucky.com
Issuing Office: Center for Biologics Evaluation and Research, United States
WARNING LETTER
CBER 26-722350
Dear Dr. Krause:
During an inspection of your firm, Louisville Reproductive ... Show Full Article WASHINGTON, Feb. 11 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Louisville Reproductive Center from the Center for Biologics Evaluation and Research: * * * Recipient: Dr. Miriam S. Krause, Medical Director, Louisville Reproductive Center, 4123 Dutchmans Lane, Suite 416, Louisville, KY 40207-4733, United States, Mkrause@ivfkentucky.com Issuing Office: Center for Biologics Evaluation and Research, United States WARNING LETTER CBER 26-722350 Dear Dr. Krause: During an inspection of your firm, Louisville ReproductiveCenter located at 4123 Dutchmans Lane, Suite 416, Louisville, KY, conducted between April 23, 2025, and April 28, 2025, the United States Food and Drug Administration (FDA) documented significant violations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) set forth in Title 21, Code of Federal Regulations (CFR) Part 1271 [21 CFR 1271] and issued under the authority of Section 361 of the Public Health Service Act [42 U.S.C. Sec. 264].
The observations documented on the Form FDA-483, List of Inspectional Observations (FDA 483), were presented to and discussed with you at the conclusion of the inspection, and following FDA's review, your violations include, but are not limited to, the following:
1) Failure to test a specimen from an anonymous or directed reproductive donor of cells or tissue, whether viable or non-viable, for evidence of infection due to relevant communicable disease agents [21 CFR 1271.85(a)]. For example:
a. Semen was collected from directed donor (b)(6) on (b)(6). However, the donor was not tested for human immunodeficiency virus, type-1 (HIV-1), hepatitis C virus (HCV), hepatitis B virus (HBV) by the nucleic acid test (NAT) method, or hepatitis B core antigen (anti-HBc). Directed semen donor (b)(6) was determined "eligible" on July 12, 2024.
b. Semen was collected from directed donor (b)(6) on (b)(6). However, the donor was not tested for West Nile Virus (WNV). Directed semen donor (b)(6) was determined "eligible" on July 12, 2024.
2) Failure to test a specimen from a donor of viable, leukocyte-rich cells or tissue for cell-associated diseases [21 CFR 1271.85(b)(1)]. For example, semen was collected from directed donor (b)(6) on (b)(6). However, the donor was not tested for Human T-lymphotropic virus, types 1 and 2 (HTLV-I and HTLV-II). Directed semen donor (b)(6) was determined "eligible" on July 12, 2024.
3) Failure to screen a donor of reproductive cells or tissue by reviewing the donor's relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases [21 CFR 1271.75(a)(1)]. Your firm's Donor Medical History Interview Questionnaire, FDA Donor Screening for Risk Factors or Conditions For Donor Eligibility Evaluator form is used as a relevant medical record to screen donors and determine their eligibility. This form is missing questions, timeframes, and/or deferral periods to assess a donor's relevant communicable disease risk. For example:
a. Question 6 states, "In the past 12 months, have you had sex with a person known or suspected to have HIV infection, active hepatitis B infection or hepatitis C infection, clinically active hepatitis B infection, or hepatitis C infection?" To adequately and appropriately reduce the risk of transmission of the disease, the question needs to ask about hepatitis B infection and clinically active (symptomatic) hepatitis C infection.
b. Question 9 states, "In the past 12 months, have you been in jail for more than 72 consecutive hours?" This question needs to ask about juvenile detention, lock up, and prison in addition to jail.
c. The form fails to ask whether donors have tested positive or reactive for WNV infection using an FDA-licensed or investigational WNV NAT donor screening test in the preceding 120 days.
d. The form fails to ask whether donors are current or former U.S. military members, civilian military employees, or dependents of a military member or civilian employee who resided at U.S. military bases in Northern Europe (Germany, Belgium, and the Netherlands) for 6 months or more cumulatively from 1980 through 1990, or elsewhere in Europe (Greece, Turkey, Spain, Portugal, and Italy) for 6 months or more cumulatively from 1980 through 1996.
e. The form fails to ask whether donors have been diagnosed with Variant Creutzfeldt-Jakob Disease (vCJD) or any other form of CJD.
4) Failure to establish and maintain procedures for all steps performed in testing, screening, and determining donor eligibility, and complying with all other requirements of Subpart C "Donor Eligibility" [21 CFR 1271.45 - 1271.90]. "Establish and maintain" means define, document, and implement; then follow, review, and as needed, revise on an ongoing basis [21 CFR 1271.47(a)]. For example, your firm's procedures do not include all steps and risk factors for donor screening, donor physical examination, steps and requirements for determining donor eligibility, and all additional relevant requirements in Subpart C of 21 CFR Part 1271.
The violations identified above are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment complies with all applicable federal regulations. You are responsible for reviewing your firm's operations, including firms within the same organization, as a whole to ensure that you are in compliance with the law.
Additional information regarding the regulation of HCT/Ps is available at:
* https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products
* https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/tissueguidances
* FDA Workshop for the Reproductive Tissue Industry - Sept 29 and Oct 1, 2020 - 09/29/2020 - 10/01/2020 | FDA
We acknowledge receipt of your email correspondence submitted on May 1, 2025, responding to the inspectional observations. We have reviewed your response, and we have determined that the response is inadequate to address our concerns. In response to Observations 1 and 2, we acknowledge your commitment to retrain staff on the donor eligibility process and donor summary of records; however, you made this commitment previously and failed to honor it. On April 8, 2021, Louisville Reproductive Center was cited for similar violations and on April 12, 2021, you responded and stated that your staff would be retrained on the Donor Summary of Records which details all required testing for semen donors. Despite that commitment, the current inspection documented the same violations, indicating that your corrective actions were either not implemented or were not effective to prevent the recurrence of the previously identified violations. The Agency continues to have serious concerns about your establishment's ability to maintain compliance with 21 CFR Part 1271.
Please note that if you still have oocytes and/or semen in storage from donors whose screening and/or testing was not completed in accordance with 21 CFR Part 1271, FDA considers the donor eligibility determinations to be incomplete for these donors. For
example, this includes donors who were not appropriately tested for relevant communicable disease agents and diseases and/or who were not appropriately screened for relevant communicable disease risk factors which includes using previous versions of donor history questionnaires that did not screen for all conditions and/or behaviors that increase a donor's relevant communicable disease risk. Therefore, as required by 21 CFR 1271.60(a), you must keep these HCT/Ps in quarantine.
Should the need arise in the future to remove any of these HCT/Ps from quarantine, either for use in your own establishment or for transport to another establishment, you may request an exemption or alternative from a requirement in Subpart C, 21 CFR Part 1271, as specified in 21 CFR 1271.155. Additional information can be found at Exemptions and Alternatives | FDA. The email address for submissions is HCTPExemptions@fda.hhs.gov.
Please note that 21 CFR 1271.155 requires that you provide justification for use of HCT/Ps from these donors, as well as information on how you have mitigated the risk consistent with the goals of protecting the public health and/or preventing the introduction, transmission, or spread of communicable diseases. Before any of these HCT/Ps can be removed from quarantine, the request must be granted by FDA.
If you still have embryos in storage for which the donor eligibility requirements under 21 CFR 1271, Subpart C are not met, please note that FDA considers the donor eligibility determinations to be incomplete for these donors. Therefore, as required by 21 CFR 1271.60(a), you must keep these HCT/Ps in quarantine. Should the need arise in the future to remove any of these HCT/Ps from quarantine, either for use in your own establishment or for transport to another establishment, you may release these HCT/Ps from quarantine [21 CFR 1271.90(b)] provided they are labeled in accordance with the applicable regulations at 21 CFR 1271.90(c).
You should take prompt action to correct any violations addressed in this letter and prevent their recurrence. Failure to promptly correct any violations may result in regulatory action being initiated by FDA without further notice.
We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to correct any violations, including an explanation of how you plan to prevent them, or similar violations, from occurring again. Additionally, include any documentation necessary to show that correction has been achieved. If you believe that your products are not in violation of the law, include your reasoning and any supporting information for our consideration. If you cannot complete all corrective actions within fifteen (15) working days, please explain the reason for your delay and the timeframe within which the remaining corrections will be completed.
Your written response should be sent to the following address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Avenue, WO71-G112, Silver Spring, MD 20993-0002. Please also email your response to CBERDCMRecommendations@fda.hhs.gov.
If you have any questions regarding this letter, please contact CBER's Division of Case Management at CBERDCMRecommendations@fda.hhs.gov. Please be advised that only written communications are considered official.
Sincerely,
/S/ Melissa J. Mendoza, Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/louisville-reproductive-center-722350-01232026