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 March 09, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
March 01, 2010	Paddock Laboratories, Inc.	Center for Drug Evaluation and Research	New Drugs	Not Issued *
March 01, 2010	Edwards Lifesciences, LLC	Center for Devices and Radiological Health	Device/Misbranded	Not Issued *
February 26, 2010	Guidewire Technologies, Inc.	New England District Office	CGMP/QSR/Medical Devices/Adulterated	September 28, 2010
February 25, 2010	Cucina Fresca, Inc.	Seattle District Office	Seafood HACCP	Not Issued *
February 25, 2010	Olympus Temmo Biomaterials Corporation - Mishima Factory	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
February 24, 2010	Centrix Pharmaceutical Inc	New Orleans District Office	New Drug/Adulterated	Not Issued *
February 24, 2010	Acquired Holding Inc	Cincinnati District Office	Seafood HACCP	Not Issued *
February 24, 2010	Mueller Water Conditioning, Inc	Dallas District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
February 23, 2010	Karl Storz	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
February 23, 2010	Arnold's Service Company, Inc.	Center for Devices and Radiological Health	UnapprovedlUncleared/Unauthorized Products Related to the H1N1 Flu Virus	Not Issued *

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