Inspections, Compliance, Enforcement, and Criminal Investigations

Warning Letters

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Tobacco Retailer Warning Letters

 

Types of Warning Letters on the FDA Website

Read more about types of warning letters

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Ways to View/Browse Warning Letters

To view Warning Letters by date:

Or:

  • Select the year from the list above in which the warning letter was issued, and browse the chronological list of warning letters on the linked page.

 

Letter Issue Date Company Name Issuing Office Subject Close Out Date
02/13/2019 Mark Berman, M.D. Los Angeles District Office Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
02/12/2019 American Preclinical Services Center for Devices and Radiological Health Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies Not Issued *
02/11/2019 Bella Pharmaceuticals, Inc. Detroit District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
02/11/2019 United Pharmacy Dallas District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
02/06/2019 Datascope Corp. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
01/29/2019 Vipor Chemicals Private Ltd. Center for Drug Evaluation and Research Vipor Chemicals Private Ltd., CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
01/29/2019 Hangzhou SunKing Nonwovens Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *

Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

Page Last Updated: 02/21/2019
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