2009 Warning Letters

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Warning Letters issued in 2009

 

* 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
December 01, 2009	Austin Fish Company	Atlanta District Office	Seafood HACCP	Not Issued *
December 01, 2009	Village Cannery Of Vermont, Inc.	New England District Office	CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated	March 03, 2010
November 30, 2009	Hyde Park Holistic Center	Center for Food Safety and Applied Nutrition	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	Not Issued *
November 30, 2009	Aregenius Worldwide LLC	Center for Drug Evaluation and Research	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	Not Issued *
November 30, 2009	www.bestswinefluvaccine.com	Center for Biologics Evaluation and Research	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	Not Issued *
November 30, 2009	Aluwe, LLC	Minneapolis District Office	Unapproved New Drug/Misbranded	Not Issued *
November 30, 2009	Chaur Fong Inc. dba 888 Food Company	Los Angeles District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *
November 27, 2009	GDMI, Inc	Dallas District Office	CGMP for Finished Pharmaceuticals/Adulterated/Misbranded	Not Issued *
November 27, 2009	ICON Clinical Research, Inc.	Center for Drug Evaluation and Research	Sponsor-Applicant-Monitor-Clinical Research Organization	Not Issued *
November 27, 2009	CFM dba Your Deli	Florida District Office	Seafood/HACCP/CGMP for Foods/Adulterated	Not Issued *
November 24, 2009	Gazda, Thomas M.D.	Center for Drug Evaluation and Research	Clinical Investigator	Not Issued *
November 24, 2009	Buettner, Craig M., MD	Center for Drug Evaluation and Research	Clinical Investigator	Not Issued *
November 24, 2009	U.F. Union International Food Company	San Francisco District Office	CGMP/Deviations/Adulterated	December 16, 2010
November 23, 2009	Quesnel Livestock	New England District Office	Illegal Drug Residue	Not Issued *
November 20, 2009	Pan American Laboratories, LLC	Center for Food Safety and Applied Nutrition	Dietary Supplement/Labeling/False & Misleading Claims/Misbranded	Not Issued *
November 20, 2009	Huaiyin Medical Instruments Co., Ltd.	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
November 20, 2009	Microsulis Medical Ltd.	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
November 20, 2009	Centra Health Inc Irb	Center for Devices and Radiological Health	Investigational Device Exemptions	Not Issued *
November 20, 2009	Wellspring International, Inc.	Minneapolis District Office	Unapproved New Drug	Not Issued *
November 19, 2009	Mason Brothers Co	Minneapolis District Office	CGMP for Foods/Seafood HACCP/Adulterated	July 13, 2011

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