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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
February 09, 2009 Ramona Farms [ARCHIVED] Dallas District Office Illegal Drug Residue N/A *
February 05, 2009 Washington Hospital IRC [ARCHIVED] Center for Biologics Evaluation and Research Institutional Review Board (IRB) N/A *
February 05, 2009 Taro Pharmaceuticals, Inc [ARCHIVED] Center for Drug Evaluation and Research CGMP for Deviations/Adulterated N/A *
February 05, 2009 Medford Veterinary Clinic [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
February 04, 2009 BestLife International, Inc. [ARCHIVED] Seattle District Office New Drug/Labeling/False & Misleading Claims N/A *
February 04, 2009 Kohler Mix Specialties of Minnesota, LLC [ARCHIVED] Minneapolis District Office Low Acid Canned Foods N/A *
February 03, 2009 ALBA Bioscience (formerly Diagnostics Scotland), SNBTS [ARCHIVED] Center for Biologics Evaluation and Research CGMP Deviations/Manufacture of Blood Grouping Reagents (BCR) N/A *
February 02, 2009 Biomed Devices Corporation (AKA: Medlens Innovations, Inc.) [ARCHIVED] Baltimore District Office CGMP/Quality System/Adulterated N/A *
February 02, 2009 Medical & Clinical Consortium Inc [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
February 02, 2009 Chappel, Christopher, MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
January 30, 2009 Acker, Randy J. [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
January 30, 2009 Lodi Veterinary Hospital, S.C. [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
January 30, 2009 Acker, Dennis L. [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
January 29, 2009 Degrave, Dale and Peggy [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
January 29, 2009 Prime Enterprises, Inc [ARCHIVED] Florida District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *
January 28, 2009 Cyclotron Center of NE Florida [ARCHIVED] Florida District Office Deviation/Adulterated N/A *
January 27, 2009 D & D Hawkins [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
January 27, 2009 Amedica Corporation [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Adulterated N/A *
January 26, 2009 Cannon Fish Company [ARCHIVED] Seattle District Office Seafood HACCP/Adulterated N/A *
January 26, 2009 First Season, Inc [ARCHIVED] Chicago District Office Seafood HACCP/Adulterated N/A *



 

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ICECI Warning Letters

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