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
Sani-Care Salon Products, Inc. Division of Pharmaceutical Quality Operations II CGMP/Finished Pharmaceuticals/Adulterated
Buy Pods Now Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Trippyvapors LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Magma Holding Inc. d/b/a EightVape Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Vape Royalty Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank Division of Biological Products Operations II Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Dollar Tree Inc. Center for Food Safety and Applied Nutrition (CFSAN) Adulterated Human Foods
Chang and Son Enterprises, Inc. Division of Human and Animal Food Operations East I CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
J&R Produce, Inc. Division of Southwest Imports Foreign Supplier Verification Program (FSVP)
Aqualex Co., Ltd. Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Unapproved New Drug/Adulterated

SUBSCRIBE

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

Back to Top