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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
Vapor Source Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
MJ Asset Holdings, LLC d/b/a Marco's Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
HotHead Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
DENTON VAPE SHOPPE Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
E-Cig Mania LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Jon B. Cole, MD Center for Drug Evaluation and Research | CDER Failure to obtain Investigational New Drug Applications
Lauren R. Klein, MD, M.S. Center for Drug Evaluation and Research | CDER Failure to obtain Investigational New Drug Applications
AriBio H&B Co., Ltd. Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
The Camel Milk Co. LLC dba Camel Culture Office of Human and Animal Foods Operations – Division West 4 New Drug/Misbranded
Magnolia Medical Technologies, Inc. Office of Medical Devices and Radiological Health, Division 3 CGMP/QSR/Medical Devices/Adulterated

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