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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
RickinmortyBars Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Vape Society Supply Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Del Valle Import & Export 3, Inc. DBA El Progreso Imports Division of West Coast Imports Foreign Supplier Verification Program (FSVP)
Safecor Health, LLC Division of Pharmaceutical Quality Operations I CGMP/Finished Pharmaceuticals/Adulterated
TRP Company, Inc Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
Natural Ophthalmics, Inc. Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
CVS Health Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
Boiron, Inc. Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
DR Vitamins, LLC dba DR Vitamin Solutions Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
Similasan AG Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug

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