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 |
|---|---|---|---|---|---|---|---|
| Greco Gas, Inc. | Office of Pharmaceutical Quality | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| EnviroServe Chemicals & Cleaners Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/Misbranded | |||||
| Aromas Para El Alma S.A. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/Misbranded |
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| St. Louis Calco, LLC | Division of Human and Animal Food Operations West II | Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated |
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| TJA Health, LLC | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Quality CDMO, Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs |
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| Exotic Wholesale LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Shenzhen Greensound High-Tech Co. Ltd. d/b/a ENVA | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Mery Vape | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Beard Management Inc. d/b/a Beard Vape Co. d/b/a Lucky Bar Holdings, d/b/a Fifty Bar | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |