Warning Letters
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 |
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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 |