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 28, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
February 05, 2010	Cardiac Science Corporation	Seattle District Office	CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded	Not Issued *
February 05, 2010	Deston Therapeutics, LLC.	Atlanta District Office	Labeling/New Drug/Misbranded	Not Issued *
February 05, 2010	Lilly del Caribe, Inc. (PR05)	San Juan District Office	CGMP/Active Pharmaceutical Ingredients/Adulterated	Not Issued *
February 04, 2010	Summers, Timothy, MD	Center for Drug Evaluation and Research	Clinical Investigator	Not Issued *
February 04, 2010	Kirk Pharmaceuticals, LLC	Florida District Office	CGMP for Finished Pharmaceuticals/Adulterated	Not Issued *
February 04, 2010	Punjwani, Sohail S., M.D.	Center for Drug Evaluation and Research	Clinical Investigator	Not Issued *
February 03, 2010	IPCH Management, Inc	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterated	Not Issued *
February 03, 2010	Garden-Fresh Foods, Inc.	Minneapolis District Office	Seafood HACCP	Not Issued *
February 02, 2010	Portal Pharmaceutical, Inc.	San Juan District Office	Labeling/New Drug Application	July 06, 2010
February 02, 2010	Societe Nouvelle Averio Maroc	Center for Food Safety and Applied Nutrition	Seafood HACCP/Adulterated	Not Issued *

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