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 |
|---|---|---|---|---|---|---|---|
| Vaporwave LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| You Suck Vapes Altus | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Brigham and Women’s Hospital Inc. | Office of Pharmaceutical Quality Operations Division I | CGMP/Positron Emission Tomography (PET) Drugs/Adulterated | |||||
| MCACO, LTD | Division of Human and Animal Food Operations West III | CGMP/Dietary Supplement/Adulterated |
|||||
| Purina Animal Nutrition LLC | Division of Human and Animal Food Operations West III | CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| Inhousepharmacy.vu | Center for Drug Evaluation and Research | CDER | Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet | |||||
| Beachside Vapors LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| David Cosmetic Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceutical/Adulterated | |||||
| Advanced Nutritional Supplements LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Dietary Supplement/Adulterated | |||||
| Exclusive Nutrition Products, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Dietary Supplement/Adulterated |