Warning Letters
Learn about the types of warning letters on FDA's website.
- Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.
- To obtain additional available information, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA Request.
- Frequently requested records may be accessed on the Reading Room page.
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
|---|---|---|---|---|---|---|---|
| Wellmill, LLC dba Vitamix Laboratories | Human Foods Program | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | … whereby they may have been rendered injurious to health. You may find the Act and the Juice HACCP regulation … Inspectional Observations, listing the deviations found at your facility. We received your responses to the … | ||||
| Bentley Laboratories LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | … was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, … oversight of your production and laboratory operations, we found your quality unit is not enabled to exercise proper … conditions specified in M006 and have not otherwise been found to be GRASE. 2 Accordingly, these products are new … | ||||
| Curia New York, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | … was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, … documentation. For example: A. Our investigators found chromatograms for testing that was performed on January … shred bins maintained in your laboratory. For example, we found an original pH meter printout slip, indicating a pH … | ||||
| Sciarra Aeromed, Inc. | Center for Veterinary Medicine | CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
… filth, or whereby it may have been rendered injurious to health." FD&C Act section 501 (a)(2)(A), 21 U.S.C. 351 (a)(2)(A). Our inspection of your facility found (b)(4) was produced under such insanitary conditions, … | ||||
| Middlefield Original Cheese Cooperative | Human Foods Program | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions | … During the inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing … FDA laboratory analyses of the environmental swabs found the presences of L. monocytogenes , a human pathogen, … filth, or whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent … | ||||
| Neogen Corporation | Center for Veterinary Medicine | CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
… contract manufacturer’s facility, located at (b)(4) , and found HYCOAT® was manufactured under insanitary conditions, … filth, or whereby it may have been rendered injurious to health." FD&C Act section 501(a)(2)(A), 21 U.S.C. … Our inspection of your contract manufacturer's site found HYCOAT® was produced under insanitary conditions, … | ||||
| South Asian Food Inc. | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | … March 9, 2026. During our inspection, the FDA investigator found serious violations of the seafood Hazard Analysis and … whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, … Inspectional Observations, listing the deviations found at your firm. After reviewing the inspectional … | ||||
| Andrighetto Produce Inc dba Shasta Produce Inc | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | … During the inspection, we found that you are not in compliance with the requirements of … procedures that provide at least the same level of public health protection as those required under section 419 of the … | ||||
| Wilson Livestock | Center for Veterinary Medicine | New Animal Drug/Adulterated | … Federal Food, Drug, and Cosmetic Act (FD&C Act) that we found during our inspection of your operation. You can find … of Animals Offered for Human Consumption Our inspection found you offered animals for sale for slaughter as food that … conditions whereby it may have been rendered injurious to health is adulterated. 5 Adulteration of a New Animal Drug … | ||||
| Fresenius Kabi USA LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | … was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, … for deviations related to biological particulate matter found in your products, including incoming inspection … if any, may be needed to avoid shortages and protect the health of patients who depend on your products. Send your … |