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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
Rash Catering Services, LLC Division of Southwest Imports FSVP/Seafood HACCP
Meditco, Inc. D.B.A. Phoenicia Specialty Foods Division of Southwest Imports FSVP/Human and Animal Foods
Seatex, LLC Division of Pharmaceutical Quality Operations II CGMP/Finished Pharmaceuticals/Adulterated
Akan Biosciences, Inc. Office of Biological Products Operations – Division I CGMP/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Central Admixture Pharmacy Services, Inc. Division of Pharmaceutical Quality Operations IV CGMP/Drug Products/Adulterated
Cookies-n-Milk, LLC Division of Human and Animal Food West III Compliance Branch (HAFW3-CB) CGMP/Packaging/Misbranded
Litehouse, Inc. Office of Human and Animal Food Operations Division East 6 CGMP Food Labeling/Allergen/Misbranded
Carbon Fire, LLC Center for Food Safety and Applied Nutrition (CFSAN) Dietary Supplement/Adulterated
Westwood Laboratories LLC Division of Pharmaceutical Quality Operations IV CGMP/Finished Pharmaceuticals/Adulterated
Central Admixture Pharmacy Services, Inc. Division of Pharmaceutical Quality Operations I CGMP/Drug Products/Adulterated

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