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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
Laboratorio Pharma International SRL Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Furley Bioextracts SDN BHD Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Nanomateriales Químicos Avanzados, S.A. de C.V. Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Fibromyalgia Treatment Group - FTG, LLC Division of Human and Animal Food Operations West VI New Drug/Misbranded
FMT Services, LLC Center for Food Safety and Applied Nutrition (CFSAN) Foreign Supplier Verification Program (FSVP)
Brilliant Enterprises LLC Office of Human and Animal Food Operations Division- East 6 Unapproved New Drugs/Misbranded
McDaniel Water, LLC Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
New York Nutrition Company / American Metabolix Division of Human and Animal Food Operations West III Unapproved New Drugs/Misbranded
Weidenhamer and Morin Enterprises LLC d/b/a Liquivape Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Chula Vista Imports Ltd. Division of Northern Border Imports Foreign Supplier Verification Program (FSVP)

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