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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
JX Restaurants, Inc. Division of Human and Animal Food Operations West II CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Westwood Laboratories LLC Division of Pharmaceutical Quality Operations IV CGMP/Finished Pharmaceuticals/Adulterated
Ng Zheng Inc. DBA Kwan Sang Noodle Company Division of Human and Animal Food Operations West IV CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
California Bread Co. Division of Human and Animal Food Operations West V Food Labeling/Misbranded
Ocean Group Inc. Division of Human and Animal Food Operations West V Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Washington Fertility Center Division of Biological Products Operations I Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Hacienda Mexican Foods, LLC Division of Human and Animal Food Operations East VI CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Cohere Beauty Division of Pharmaceutical Quality Operations IV CGMP/Finished Pharmaceuticals/Adulterated
Vintage Chemical Inc. Division of Pharmaceutical Quality Operations III CGMP/Finished Pharmaceuticals/Adulterated
Seatex, LLC Division of Pharmaceutical Quality Operations II CGMP/Finished Pharmaceuticals/Adulterated

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