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 |
|---|---|---|---|---|---|---|---|
| Electric Smoke Vapor House | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| AZ Swagg Sauce LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Elite Supplement Center LLC and Elite Training Facility LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug | |||||
| W.H.P.M, Inc. | Office of Medical Device and Radiological Health Division 3 | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |||||
| Noticias Mexico Hoy Grupo Multimedia, S.A. de C.V. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
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| DDI Multinacional S.A. de C.V. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | |||||
| Thirsty Run LLC / US Royal Honey LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Internet Marketing of Unapproved and Misbranded Drugs | |||||
| 1am USA Incorporated dba Pleasure Products USA | Center for Food Safety and Applied Nutrition (CFSAN) | Internet Marketing of Unapproved and Misbranded Drugs | |||||
| Shopaax.com | Center for Food Safety and Applied Nutrition (CFSAN) | Interstate Commerce/Food/Adulterated | |||||
| MKS Enterprise, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Interstate Commerce/Food/Adulterated |