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
09/26/2023	09/18/2023	Zhao Qing Longda Biotechnology Co. Ltd.	Center for Drug Evaluation and Research | CDER	Refusal to Provide Access to and Copying of Records
09/26/2023	09/12/2023	Gulf States International, Inc.	Center for Drug Evaluation and Research | CDER	Refusal to Provide Access to and Copying of Records
09/26/2023	09/05/2023	PT. Winson Prima Sejahtera	Center for Food Safety and Applied Nutrition (CFSAN)	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
09/21/2023	09/21/2023	Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Howell	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
09/21/2023	09/21/2023	Caribbean Cloud Dot Com d/b/a Gorilla Vapes	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
09/21/2023	09/21/2023	Top Shelf Vaping LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
09/19/2023	08/21/2023	VCI Enterprise, Inc d/b/a DRIPTECH	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
09/19/2023	09/14/2023	Maison Blanche LLC	Center for Drug Evaluation and Research | CDER	Refusal to Provide Access to and Copying of Records
09/19/2023	09/12/2023	Walgreen Company	Center for Drug Evaluation and Research | CDER	Failure to Register and List
09/19/2023	09/11/2023	Kor-Chem, Inc.	Division of Pharmaceutical Quality Operations II	CGMP/Finished Pharmaceuticals/Adulterated

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