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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
Modfathers Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Southbound Vapes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
HIS Enterprise Inc dba Adam’s Secret USA, LLC Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Optum Infusion Services 308 LLC Division of Pharmaceutical Quality Operations IV Compounding Pharmacy/Adulterated Drug Products
Tiger Vapes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Chevaline Investments dba VaporCore Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Chevaline Investments dba VaporCore Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Purecraft LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Medical Mikes, Inc. Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
San-Rey Produce Inc. Division of Southwest Imports Foreign Supplier Verification Program (FSVP)

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