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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
Innova Medical Group, Inc. Center for Devices and Radiological Health Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Perfection Vapes Inc Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Neptunus Seafood B.V. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated
Kareem Mart Inc. Div ision of Northern Border Imports Foreign Supplier Verification Program (FSVP)
DMM Vission, S.A. de C.V. Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Red's Kitchen Sink at Bourbon Street Ice Office of Human and Animal Food Operations – East Division 3 New Drug/Misbranded
Everything Health LLC Center for Food Safety and Applied Nutrition Unapproved and Misbranded Products Related to Coronavirus Disease 2019(COVID-19)
Beauty & Spa Concepts, DBA Beenefits Center for Food Safety and Applied Nutrition Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
PurePurge Inc. Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Castle Rock Vapor LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

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