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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
Zhao Qing Longda Biotechnology Co. Ltd. Center for Drug Evaluation and Research | CDER Refusal to Provide Access to and Copying of Records
Gulf States International, Inc. Center for Drug Evaluation and Research | CDER Refusal to Provide Access to and Copying of Records
PT. Winson Prima Sejahtera Center for Food Safety and Applied Nutrition (CFSAN) Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Howell Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Caribbean Cloud Dot Com d/b/a Gorilla Vapes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Top Shelf Vaping LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
VCI Enterprise, Inc d/b/a DRIPTECH Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Maison Blanche LLC Center for Drug Evaluation and Research | CDER Refusal to Provide Access to and Copying of Records
Walgreen Company Center for Drug Evaluation and Research | CDER Failure to Register and List
Kor-Chem, Inc. Division of Pharmaceutical Quality Operations II CGMP/Finished Pharmaceuticals/Adulterated

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