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 April 20, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
April 05, 2010	7Seas LLC	Florida District Office	Dietary Supplement Regulations/Misbranded	Not Issued *
April 05, 2010	All About You Medspa, LLC	Center for Drug Evaluation and Research	Lipodissolve/False & Misleading Claims/Misbranded	Not Issued *
April 02, 2010	Wright Place, LLC	New England District Office	Illegal Drug Residue	Not Issued *
April 01, 2010	Yurkanin, John B	Philadelphia District Office	Illegal Drug Residue	Not Issued *
April 01, 2010	Deitz, Robert, M.D.	Center for Drug Evaluation and Research	Clinical Investigator	Not Issued *
March 31, 2010	Cut Fruit Express, Inc.	Minneapolis District Office	CGMP for Foods/HACCP/Adulterated	February 08, 2011
March 30, 2010	Coats International Holdings, Inc	Dallas District Office	CGMP Manufacture, Processing, Packing or Holding/Adulterated	Not Issued *
March 30, 2010	Wisconsin Brother's Bakery, Inc	Minneapolis District Office	Labeling/False & Misleading Claims/Misbranded	Not Issued *
March 29, 2010	IVF Phoenix	Los Angeles District Office	Human Cells, Tissues & Cellular Products	July 18, 2011
March 29, 2010	Apotex Inc.	Center for Drug Evaluation and Research	CGMP for Finished Pharmaceuticals/Adulterated	July 01, 2011

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