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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 16, 2009 American Optisurgical Inc [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 16, 2009 American Mammographics Inc [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 13, 2009 Syntec Nutraceuticals, Inc [ARCHIVED] Minneapolis District Office Promotional Claims False & Misleading/New Drugs N/A *
March 13, 2009 Blackstone Medical Inc. [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 12, 2009 Provena St. Joseph's Medical Center IRB Center for Biologics Evaluation and Research Institutional Review Board (IRB) N/A *
March 12, 2009 Express Diagnostics Int'l., Inc [ARCHIVED] Minneapolis District Office Premarket Approval/Misbranded/Adulterated N/A *
March 11, 2009 Best Vascular Inc [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
March 11, 2009 Paulson, Daniel M., MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
March 10, 2009 Brann Farms [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
March 09, 2009 Merlin Labs, Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 06, 2009 D M L Venture Enterprises [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
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 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 *



 

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ICECI Warning Letters

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