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 |
|---|---|---|---|---|---|---|---|
| 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 | |||||
| Carbon Fire, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Dietary Supplement/Adulterated |
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| Coombe Castle International Ltd. | Center for Food Safety and Applied Nutrition (CFSAN) | Low Acid Canned Food Regulation/Adulterated |
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| G.N.R. Group Co., LTD. | Center for Food Safety and Applied Nutrition (CFSAN) | Juice/HACCP/Adulterated |
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| Grupo Quimico SRL | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Ng Zheng Inc. DBA Kwan Sang Noodle Company | Division of Human and Animal Food Operations West IV | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| California Bread Co. | Division of Human and Animal Food Operations West V | Food Labeling/Misbranded | |||||
| Ocean Group Inc. | Division of Human and Animal Food Operations West V | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |