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 February 23, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
February 12, 2010	LCA Vision Inc/Lasik Plus Vision Center	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	August 16, 2011
February 12, 2010	Lasik Vision Institute	Center for Devices and Radiological Health	Medical Device Reporting Regulation/Misbranded	Not Issued *
February 11, 2010	Rangen Inc	Seattle District Office	Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded	Not Issued *
February 09, 2010	Lomeo, Simon J.	New York District Office	Illegal Drug Residue	Not Issued *
February 09, 2010	Breckenridge Pharmaceutical, Inc.	Florida District Office	New Drug/Adulterated	Not Issued *
February 09, 2010	P & D Dairy	Los Angeles District Office	Illegal Drug Residue	Not Issued *
February 08, 2010	Poly Pharmaceuticals, Inc	New Orleans District Office	New Drug/Adulterated	Not Issued *
February 08, 2010	Magna Pharmaceuticals, Inc	Cincinnati District Office	Labeling/False & Misleading Claims/New Drug/Misbranded	Not Issued *
February 08, 2010	Jaymac Pharmaceuticals LLC	New Orleans District Office	New Drug/Adulterated	Not Issued *
February 08, 2010	Edwards Pharmaceuticals, Inc	New Orleans District Office	New Drug/Adulterated	Not Issued *

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