2010 Warning Letters

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Warning Letters issued in 2010

 

* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.

Read more about warning and close-out letters

Posted on July 19, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
June 25, 2010	AMPAC Fine Chemicals, LLC	San Francisco District Office	CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated	April 25, 2011
June 25, 2010	American Pecan Co. LLC	Dallas District Office	CGMP for Foods/Labeling/Adulterated/Misbranded	Not Issued *
June 25, 2010	Pozner, Jason M.D.	Center for Devices and Radiological Health	Investigational Device Exemptions (Clinical Investigator)	Not Issued *
June 24, 2010	Thumb Oilseed Producers' Cooperative	Detroit District Office	CGMP Regulation For Food/Adulterated	Not Issued *
June 24, 2010	North Memorial Medical Center	Center for Devices and Radiological Health	Institutional Review Board (IRB)	Not Issued *
June 23, 2010	Basic Food Flavors, Inc.	San Francisco District Office	CGMP/Foods/Insanitary Conditions	Not Issued *
June 23, 2010	Oregon Health & Science University	Seattle District Office	Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products	Not Issued *
June 23, 2010	Blountys, LLC	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterated	Not Issued *
June 22, 2010	Nanjing Pharmaceutical Factory Company Limited	Center for Veterinary Medicine	CGMP/Active Pharmaceutical Ingredient Manufacturing Facility/Adulterated	Not Issued *
June 22, 2010	MedCentral Health System	Center for Devices and Radiological Health	Institutional Review Board (IRB)	Not Issued *

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