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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
My Vapor Den DBA Nu Age Smoke & Vape Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Exactech, Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated
Boehringer Ingelheim Animal Health USA Center for Veterinary Medicine False & Misleading Claims/Misbranded
Nobles Medical Technology II, Inc. Center for Devices and Radiological Health Investigational Review Board (IRB)
Spirochaete Research Labs, LLC aka Scitus Laboratory Products Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
Human Microbes Center for Biologics Evaluation and Research (CBER) CGMP/Deviations/Biologics License Application (BLA)
Better Vapes LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
FLVRS US, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Vaping Studio Inc Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Colgin, Inc. Division of Pharmaceutical Quality Operations II CGMP/Finished Pharmaceuticals/Adulterated

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