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  1. Compliance Actions and Activities

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
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
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
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

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