U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  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
Liquivape Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Switch to Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Noble Elements, LLC Center for Food Safety and Applied Nutrition (CFSAN) Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Organic Heirloom Plants Center for Food Safety and Applied Nutrition (CFSAN) Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Dr. Green Mom, LLC Center for Food Safety and Applied Nutrition (CFSAN) Finished Pharmaceuticals/Unapproved New Drug/Misbranded
RightEye, LLC Division of Medical Device and Radiological Health Operations East Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Urban Electric Power Division of Pharmaceutical Quality Operations I CGMP/Drug Products/Adulterated
Mohawk Laboratories Division of NCH Corporation Division of Pharmaceutical Quality Operations II CGMP/Drug Products/Adulterated
Old Tiles Wallpaper, LLC DBA Old Tiles Decor Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Monkeypox-treatment.com Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded

SUBSCRIBE

Get regular FDA email updates delivered on this topic to your inbox.

Back to Top