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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Wolfe Trading Company LLC d/b/a East Coast Vapors | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
8OHM1 d/b/a Digital Smoke | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
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Velvet Vapor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Jams Vaporium | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
HomeTown Vapor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
ALI Pharmaceutical Manufacturing, LLC | Division of Pharmaceutical Quality Operations III | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||||
Samm Solutions, Inc., d.b.a. BTS Research | Center for Drug Evaluation and Research | CDER | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies |
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WAVi Co. | Division of Medical Device and Radiological Health Operations West | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | |||||
Maria W. Greenwald, M.D. | Center for Drug Evaluation and Research | CDER | Clinical Investigator | |||||
Cajun Vapes LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |