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
JJDS E Cigarettes LLC d/b/a TKO Vapor Overstock Ecigs & More Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Black Hills Vapors LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
DNA Distributors, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Bootstrap Runners LLC d/b/a Sinister Liquids Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Kim Nhung Marketplace Inc Division of West Coast Imports Foreign Supplier Verification Program (FSVP)
HealthMEDS Inc. Center for Drug Evaluation and Research | CDER Failure to permit access to or copying of records
Notarika, S.A. de C.V. Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
GuangZhou YouXing Cosmetic Co., Ltd Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc. Center for Drug Evaluation and Research | CDER Bioresearch Monitoring Program/IRB
Missouri Analytical Laboratories Inc Division of Pharmaceutical Quality Operations III CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

SUBSCRIBE

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

Back to Top