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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
South Coast Vapor Company Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Dr. Vape It, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Amcyte Pharma, Inc. Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)
Slam Cake Vapes LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Vasyl Melnyk, M.D. Center for Drug Evaluation and Research | CDER Bioresearch Monitoring Program/IRB
Varigard, LLC Center for Drug Evaluation and Research | CDER Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
Lady Boss Vapor Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
DSAART, LLC. dba Alpha Aesthetics Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated
Cosmic Fog Vapors Operating Company, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Spartan Chemical Company, Inc. Division of Pharmaceutical Quality Operations III CGMP/Finished Pharmaceuticals/Adulterated

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