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 |
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Zhao Qing Longda Biotechnology Co. Ltd. | Center for Drug Evaluation and Research | CDER | Refusal to Provide Access to and Copying of Records | |||||
Gulf States International, Inc. | Center for Drug Evaluation and Research | CDER | Refusal to Provide Access to and Copying of Records | |||||
PT. Winson Prima Sejahtera | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||||
Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Howell | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
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Caribbean Cloud Dot Com d/b/a Gorilla Vapes | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
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Top Shelf Vaping LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
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VCI Enterprise, Inc d/b/a DRIPTECH | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Maison Blanche LLC | Center for Drug Evaluation and Research | CDER | Refusal to Provide Access to and Copying of Records | |||||
Walgreen Company | Center for Drug Evaluation and Research | CDER | Failure to Register and List | |||||
Kor-Chem, Inc. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated |