Warning Letters

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.

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Letters with Response or Closeout

Posted Date

Year

Posted Date	Letter Issue Date	Company Name	Issuing Office	Subject
08/08/2023	07/26/2023	US Specialty Formulations, LLC	Division of Pharmaceutical Quality Operations I	Compounding Pharmacy/Adulterated Drug Products
08/08/2023	08/03/2023	Fancystage Unipessoal, LDA	Center for Drug Evaluation and Research \| CDER	CGMP/Finished Pharmaceuticals/Adulterated
08/08/2023	08/03/2023	Avaria Health & Beauty Corp.	Center for Drug Evaluation and Research \| CDER	CGMP/Finished Pharmaceuticals/Adulterated
08/08/2023	08/03/2023	LCC Ltd.	Center for Drug Evaluation and Research \| CDER	CGMP/Finished Pharmaceuticals/Adulterated
08/08/2023	08/03/2023	Suhan Aerosol	Center for Drug Evaluation and Research \| CDER	CGMP/Finished Pharmaceuticals/Adulterated
08/08/2023	07/21/2023	STC India Private Limited	Center for Food Safety and Applied Nutrition (CFSAN)	CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
08/08/2023	08/03/2023	KM Pharmaceutical Co. Ltd.	Center for Drug Evaluation and Research \| CDER	Refusal to Provide Access to and Copying of Records
08/08/2023	08/03/2023	Orchid Lifesciences	Center for Drug Evaluation and Research \| CDER	CGMP/Finished Pharmaceuticals/Adulterated
08/08/2023	08/03/2023	Tan Alize Kozmetik Ve Temizlik Urunleri	Center for Drug Evaluation and Research \| CDER	CGMP/Finished Pharmaceuticals/Adulterated
08/08/2023	08/03/2023	Sangleaf Pharm., Co. Ltd.	Center for Drug Evaluation and Research \| CDER	Failure to Provide Information