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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
March 03, 2009 Quinones, Manuel J., MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
March 02, 2009 Desai, Virendra M., MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
March 02, 2009 Cote, Charles J., MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
February 27, 2009 Genzyme Corporation [ARCHIVED] New England District Office CGMP Deviations N/A *
February 27, 2009 Nonna's Real Italiana Cuccine [ARCHIVED] New Orleans District Office Seafood HACCP/Adulterated N/A *
February 26, 2009 IVD Research, Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
February 23, 2009 Guggisberg Cheese, Inc. dba Deutsch Kase Haus [ARCHIVED] Detroit District Office Nutrition Labeling of Food/Misbranded N/A *
February 23, 2009 Sing Kung Corporation [ARCHIVED] Los Angeles District Office Acidified Foods/Adulterated N/A *
February 18, 2009 PETMED EXPRESS, INC [ARCHIVED] Florida District Office New Animal Drug/Adulterated N/A *
February 18, 2009 Atlantic Coast Seafood Inc. [ARCHIVED] New England District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
February 18, 2009 PetMed Express, Inc. [ARCHIVED] Florida District Office New Animal Drug/Adulterated N/A *
February 18, 2009 Wright, Richard A, MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
February 18, 2009 Brymill Corporation [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
February 17, 2009 Washington Biotechnology, Inc [ARCHIVED] Center for Biologics Evaluation and Research Good Laboratory Practice (GLP) N/A *
February 12, 2009 Bass Medical Inc [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
February 12, 2009 Dunedin Fish Company [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
February 12, 2009 Bass Medical Inc [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
February 11, 2009 Health Science Center Brooklyn Kings County [ARCHIVED] Center for Drug Evaluation and Research Institutional Review Board (IRB) N/A *
February 11, 2009 Mark V. Porter d.b.a. MVP Livestock, Inc. [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
February 09, 2009 Omega Laboratories Inc. [ARCHIVED] Cincinnati District Office Premarket Approval/Adulterated N/A *



 

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ICECI Warning Letters

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