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 June 22, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
June 16, 2010	Oxford Falls	New Orleans District Office	Food Labeling/Misbranded	June 27, 2012
June 15, 2010	Skogen, John L.	Minneapolis District Office	Illegal Drug Residue	November 15, 2010
June 15, 2010	Union Development Frozen Foods Co., Ltd	Center for Food Safety and Applied Nutrition	Seafood HACCP/Adulterated/Misbranded	Not Issued *
June 14, 2010	Catalina Offshore Products, Inc	Los Angeles District Office	Seafood HACCP/CGMP for Foods/Adulterated	March 14, 2011
June 11, 2010	Optovue Inc.	San Francisco District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	February 23, 2012
June 10, 2010	Medefil Incorporated	Chicago District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
June 10, 2010	Nicola Pizza Inc.	Philadelphia District Office	CGMP for Foods/Labeling/Misbranded	Not Issued *
June 10, 2010	Libido Edge Labs, Llc	Cincinnati District Office	Unapproved New Drug Promotional Claims/Misbranded	Not Issued *
June 10, 2010	Clearview Farms	Cincinnati District Office	Illegal Drug Residue	Not Issued *
June 09, 2010	Adamis Pharmaceuticals	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	February 15, 2011

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