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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
March 12, 2009 Express Diagnostics Int'l., Inc Minneapolis District Office Premarket Approval/Misbranded/Adulterated N/A *
March 11, 2009 Best Vascular Inc Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
March 11, 2009 Paulson, Daniel M., MD Center for Drug Evaluation and Research Clinical Investigator N/A *
March 10, 2009 Brann Farms Seattle District Office Illegal Drug Residue N/A *
March 09, 2009 Merlin Labs, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 06, 2009 D M L Venture Enterprises Florida District Office Seafood HACCP/Adulterated N/A *
March 03, 2009 Quinones, Manuel J., MD Center for Drug Evaluation and Research Clinical Investigator N/A *
March 02, 2009 Desai, Virendra M., MD Center for Drug Evaluation and Research Clinical Investigator N/A *
March 02, 2009 Cote, Charles J., MD Center for Drug Evaluation and Research Clinical Investigator N/A *
February 27, 2009 Genzyme Corporation New England District Office CGMP Deviations N/A *
February 27, 2009 Nonna's Real Italiana Cuccine New Orleans District Office Seafood HACCP/Adulterated N/A *
February 26, 2009 IVD Research, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
February 23, 2009 Guggisberg Cheese, Inc. dba Deutsch Kase Haus Detroit District Office Nutrition Labeling of Food/Misbranded N/A *
February 23, 2009 Sing Kung Corporation Los Angeles District Office Acidified Foods/Adulterated N/A *
February 18, 2009 PETMED EXPRESS, INC Florida District Office New Animal Drug/Adulterated N/A *
February 18, 2009 Atlantic Coast Seafood Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
February 18, 2009 PetMed Express, Inc. Florida District Office New Animal Drug/Adulterated N/A *
February 18, 2009 Wright, Richard A, MD Center for Drug Evaluation and Research Clinical Investigator N/A *
February 18, 2009 Brymill Corporation New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
February 17, 2009 Washington Biotechnology, Inc Center for Biologics Evaluation and Research GLP/Bioresearch Monitoring Program N/A *



 

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