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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 30, 2009 Roxane Laboratories, Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 30, 2009 Boehringer Ingelheim Roxane Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 30, 2009 Bukowski, Ronald M, MD Center for Drug Evaluation and Research Clinical Investigator N/A *
March 30, 2009 Cody Laboratories, Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 30, 2009 Xanodyne Pharmaceuticals Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 30, 2009 Physicians Total Care, Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 30, 2009 Dragon Waves Frozen Food Factory Co., Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP N/A *
March 30, 2009 Mallinckrodt Inc. Pharmaceuticals Group Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 30, 2009 Glenmark Generics Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded N/A *
March 27, 2009 Templeton Dairy LLC Minneapolis District Office Illegal Drug Residue N/A *
March 24, 2009 Dyna-Moo Dairy, LLC Seattle District Office Illegal Drug Residue N/A *
March 20, 2009 Interior Alaska Fish Processor Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
March 20, 2009 Safie Specialty Foods Co., Inc Detroit District Office Acidified Foods/Adulterated N/A *
March 20, 2009 Square One Foods Minneapolis District Office Food Labeling Misbranded N/A *
March 19, 2009 W.H.P.M., Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 16, 2009 American Mammographics Inc New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 16, 2009 American Optisurgical Inc Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 13, 2009 Blackstone Medical Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 13, 2009 Syntec Nutraceuticals, Inc Minneapolis District Office Promotional Claims False & Misleading/New Drugs N/A *
March 12, 2009 Provena St. Joseph's Medical Center IRB Center for Biologics Evaluation and Research Bioresearch Monitoring Program/IRB N/A *



 

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