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
Juicemafia Inc. d/b/a ECIG-Works Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
180 Vape E-Cigs & Lounge Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Juicemafia, Inc. d/b/a Ecig-Works Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Lakpura LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Advanced Cosmetic Research Laboratories Inc. Division of Pharmaceutical Quality Operations IV CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Ragin’ Vapors Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
RiteAid Corporation Center for Drug Evaluation and Research | CDER Failure to Comply with Drug Listing Requirements/Misbranded
Nicotine River LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Nephron SC Inc. Office of Pharmaceutical Quality Operations, Division II CGMP/Finished Pharmaceuticals/Adulterated
El Gordo Spices, LLC Division of Human and Animal Food Operations West III Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

SUBSCRIBE

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

Back to Top