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 September 07, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
August 19, 2010	B & A Health Products Inc	Los Angeles District Office	Labeling/OTC Drugs/Misbranded	Not Issued *
August 19, 2010	Healex Products Inc.	New England District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	Not Issued *
August 19, 2010	Depuy Orthopaedics, Inc.	Center for Devices and Radiological Health	Premarket Approval/Adulterated/Misbranded	Not Issued *
August 19, 2010	Peslasa S.A.	Center for Food Safety and Applied Nutrition	Seafood HACCP/CGMP for Foods/Adulterated	November 30, 2010
August 18, 2010	MN Airlines LLC dba Sun Country Airlines	Los Angeles District Office	Interstate Conveyance Sanitation Regulations	Not Issued *
August 17, 2010	Ken Corscadden	New York District Office	Animal Sale for Slaughter as Food/Adulterated	Not Issued *
August 17, 2010	AMRI Burlington, Inc. (formerly Hyaluron, Inc.)	New England District Office	Current Good Manufacturing Practice for Finished Pharmaceuticals/Adulterated	Not Issued *
August 16, 2010	R&P Seafood Corp.	Los Angeles District Office	Seafood HACCP/CGMP for Foods/Adulterated	Not Issued *
August 16, 2010	Herman A. Jenkins, M.D.	Center for Devices and Radiological Health	Premarket Approval Application	March 21, 2011
August 13, 2010	Juice Pac Inc	Cincinnati District Office	Juice/HACCP/Adulterated	Not Issued *

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