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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
Glenmark Pharmaceuticals Limited Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Adulterated
Saffron USA LLC Division of Human and Animal Food Operations East IV Unapproved New Drugs/Misbranded
Cryos International USA LLC Division of Biological Products Operations I Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Zuland Distributor Corp Division of Southwest Imports Foreign Supplier Verification Program (FSVP)
Manzela USA, LLC Division of Southwest Imports Foreign Supplier Verification Program (FSVP)
Maliba African Market Corp. Division of Northeast Imports Foreign Supplier Verification Program (FSVP)
Kari Gran Inc. Division of Pharmaceutical Quality Operations IV CGMP/Finished Pharmaceuticals/Adulterated
AG Hair Limited Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Adulterated
Vapor Candy Inc d/b/a The Vape Stop Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Jayde's Vapor Lounge Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

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