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 |
|---|---|---|---|---|---|---|---|
| Amarillo Snuff Co. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Game Trader | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Illumivaption Inc. dba Nashville Vapor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| US Specialty Formulations, LLC | Division of Pharmaceutical Quality Operations I | Compounding Pharmacy/Adulterated Drug Products | |||||
| STC India Private Limited | Center for Food Safety and Applied Nutrition (CFSAN) | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
|||||
| Avaria Health & Beauty Corp. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Fancystage Unipessoal, LDA | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
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| GTP International Corp | Center for Drug Evaluation and Research | CDER | Refusal to Provide Access to and Copying of Records | |||||
| Cergomex Imports, LLC | Center for Drug Evaluation and Research | CDER | Refusal to Provide Access to and Copying of Records | |||||
| Sangleaf Pharm., Co. Ltd. | Center for Drug Evaluation and Research | CDER | Failure to Provide Information |