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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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
February 12, 2009 Bass Medical Inc New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
February 12, 2009 Bass Medical Inc New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
February 12, 2009 Dunedin Fish Company Florida District Office Seafood HACCP/Adulterated N/A *
February 11, 2009 Health Science Center Brooklyn Kings County Center for Drug Evaluation and Research Institutional Review Board (IRB) N/A *
February 11, 2009 Mark V. Porter d.b.a. MVP Livestock, Inc. Seattle District Office Illegal Drug Residue N/A *
February 09, 2009 Ramona Farms Dallas District Office Illegal Drug Residue N/A *
February 09, 2009 Omega Laboratories Inc. Cincinnati District Office Premarket Approval/Adulterated N/A *
February 05, 2009 Taro Pharmaceuticals, Inc Center for Drug Evaluation and Research CGMP for Deviations/Adulterated N/A *
February 05, 2009 Medford Veterinary Clinic Minneapolis District Office Illegal Drug Residue N/A *
February 05, 2009 Washington Hospital IRC Center for Biologics Evaluation and Research Institutional Review Board (IRB) N/A *
February 04, 2009 Kohler Mix Specialties of Minnesota, LLC Minneapolis District Office Low Acid Canned Foods N/A *
February 04, 2009 BestLife International, Inc. Seattle District Office New Drug/Labeling/False & Misleading Claims N/A *
February 03, 2009 ALBA Bioscience (formerly Diagnostics Scotland), SNBTS Center for Biologics Evaluation and Research CGMP Deviations/Manufacture of Blood Grouping Reagents (BCR) N/A *
February 02, 2009 Medical & Clinical Consortium Inc Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
February 02, 2009 Chappel, Christopher, MD Center for Drug Evaluation and Research Clinical Investigator N/A *
February 02, 2009 Biomed Devices Corporation (AKA: Medlens Innovations, Inc.) Baltimore District Office CGMP/Quality System/Adulterated N/A *
January 30, 2009 Acker, Dennis L. Minneapolis District Office Illegal Drug Residue N/A *
January 30, 2009 Lodi Veterinary Hospital, S.C. Minneapolis District Office Illegal Drug Residue N/A *
January 30, 2009 Acker, Randy J. Minneapolis District Office Illegal Drug Residue N/A *
January 29, 2009 Prime Enterprises, Inc Florida District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *



 

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ICECI Warning Letters

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