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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
Juice Roll Upz, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
New Green Nutrition, Inc. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Empower Clinic Services, LLC dba Empower Pharmacy Office of Pharmaceutical Quality Operations, Division II Compounding Pharmacy/Adulterated Drug Products
Joseph A. Zadra, M.D. Center for Drug Evaluation and Research | CDER Clinical Investigator
Flair Products LLC/Flair Vapor LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Vertigo Vapor Inc. d/b/a Baton Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Organa International Corp. Office of Human and Animal Food Operations Division West 4 Unapproved New Drugs/Misbranded
Vapor Rage LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Owlet Baby Care, Inc. Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Databazaar.com Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019

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