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.
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
|---|---|---|---|---|---|---|---|
| Central Admixture Pharmacy Services, Inc. | Division of Pharmaceutical Quality Operations IV | CGMP/Drug Products/Adulterated | |||||
| Cookies-n-Milk, LLC | Division of Human and Animal Food West III Compliance Branch (HAFW3-CB) | CGMP/Packaging/Misbranded | |||||
| Rash Catering Services, LLC | Division of Southwest Imports | FSVP/Seafood HACCP | |||||
| Meditco, Inc. D.B.A. Phoenicia Specialty Foods | Division of Southwest Imports | FSVP/Human and Animal Foods | |||||
| Seatex, LLC | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Akan Biosciences, Inc. | Office of Biological Products Operations – Division I | CGMP/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | |||||
| Litehouse, Inc. | Office of Human and Animal Food Operations Division East 6 | CGMP Food Labeling/Allergen/Misbranded |
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| Blue Caribbean Foods Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated | |||||
| Central Admixture Pharmacy Services, Inc. | Division of Pharmaceutical Quality Operations I | CGMP/Drug Products/Adulterated | |||||
| Natuzen Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |