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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
FluxxLab LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Brew City Juice, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
DSP Skin Care LLC Division of Pharmaceutical Quality Operations IV CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Transworld International Trading Corp. Division of Northeast Imports Foreign Supplier Verification Program (FSVP)
CVM 3, LLC d/b/a Carolina Vapor Mill Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Electrik Smoke LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Boosted LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Walker Trading Co. Inc. d/b/a Vape Dojo Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Ferrum City Liquid Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Gentleman’s Draw LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

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