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U.S. Department of Health and Human Services

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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
03/02/2009 Desai, Virendra M., MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
03/02/2009 Cote, Charles J., MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
02/27/2009 Genzyme Corporation [ARCHIVED] New England District Office CGMP Deviations N/A *
02/27/2009 Nonna's Real Italiana Cuccine [ARCHIVED] New Orleans District Office Seafood HACCP/Adulterated N/A *
02/26/2009 IVD Research, Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
02/23/2009 Guggisberg Cheese, Inc. dba Deutsch Kase Haus [ARCHIVED] Detroit District Office Nutrition Labeling of Food/Misbranded N/A *
02/23/2009 Sing Kung Corporation [ARCHIVED] Los Angeles District Office Acidified Foods/Adulterated N/A *
02/18/2009 PETMED EXPRESS, INC [ARCHIVED] Florida District Office New Animal Drug/Adulterated N/A *
02/18/2009 Atlantic Coast Seafood Inc. [ARCHIVED] New England District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
02/18/2009 PetMed Express, Inc. [ARCHIVED] Florida District Office New Animal Drug/Adulterated N/A *
02/18/2009 Wright, Richard A, MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
02/18/2009 Brymill Corporation [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
02/17/2009 Washington Biotechnology, Inc [ARCHIVED] Center for Biologics Evaluation and Research Good Laboratory Practice (GLP) N/A *
02/12/2009 Bass Medical Inc [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
02/12/2009 Dunedin Fish Company [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
02/12/2009 Bass Medical Inc [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
02/11/2009 Health Science Center Brooklyn Kings County [ARCHIVED] Center for Drug Evaluation and Research Institutional Review Board (IRB) N/A *
02/11/2009 Mark V. Porter d.b.a. MVP Livestock, Inc. [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
02/09/2009 Omega Laboratories Inc. [ARCHIVED] Cincinnati District Office Premarket Approval/Adulterated N/A *
02/09/2009 Ramona Farms [ARCHIVED] Dallas District Office Illegal Drug Residue N/A *
02/05/2009 Washington Hospital IRC [ARCHIVED] Center for Biologics Evaluation and Research Institutional Review Board (IRB) N/A *
02/05/2009 Taro Pharmaceuticals, Inc [ARCHIVED] Center for Drug Evaluation and Research CGMP for Deviations/Adulterated N/A *
02/05/2009 Medford Veterinary Clinic [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
02/04/2009 BestLife International, Inc. [ARCHIVED] Seattle District Office New Drug/Labeling/False & Misleading Claims N/A *
02/04/2009 Kohler Mix Specialties of Minnesota, LLC [ARCHIVED] Minneapolis District Office Low Acid Canned Foods N/A *
02/03/2009 ALBA Bioscience (formerly Diagnostics Scotland), SNBTS [ARCHIVED] Center for Biologics Evaluation and Research CGMP Deviations/Manufacture of Blood Grouping Reagents (BCR) N/A *
02/02/2009 Biomed Devices Corporation (AKA: Medlens Innovations, Inc.) [ARCHIVED] Baltimore District Office CGMP/Quality System/Adulterated N/A *
02/02/2009 Medical & Clinical Consortium Inc [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
02/02/2009 Chappel, Christopher, MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
01/30/2009 Acker, Randy J. [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
01/30/2009 Lodi Veterinary Hospital, S.C. [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
01/30/2009 Acker, Dennis L. [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
01/29/2009 Degrave, Dale and Peggy [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
01/29/2009 Prime Enterprises, Inc [ARCHIVED] Florida District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *
01/28/2009 Cyclotron Center of NE Florida [ARCHIVED] Florida District Office Deviation/Adulterated N/A *
01/27/2009 D & D Hawkins [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
01/27/2009 Amedica Corporation [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Adulterated N/A *
01/26/2009 Cannon Fish Company [ARCHIVED] Seattle District Office Seafood HACCP/Adulterated N/A *
01/26/2009 First Season, Inc [ARCHIVED] Chicago District Office Seafood HACCP/Adulterated N/A *
01/23/2009 Mainline Technology, Inc [ARCHIVED] Detroit District Office CGMP/QSR/Medical Devices/Adulterated N/A *
01/22/2009 Sage Products Inc [ARCHIVED] Chicago District Office CGMP Manufacturer, Processsing, Packing, Holding Drugs/Devices/Adulterated N/A *
01/21/2009 Stewart, Lynette D. M.D [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
01/20/2009 Nidek Medical Products Inc [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
01/15/2009 Haelan Products [ARCHIVED] Seattle District Office Promotional Claims False & Misleading/New Drug/Misbranded N/A *
01/15/2009 Portland Shellfish Company, Inc. [ARCHIVED] New England District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
01/14/2009 Brewer, George J. M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
01/14/2009 Healthy Origins [ARCHIVED] Philadelphia District Office Labeling/False & Misleading Claims/New Drug/Misbranded N/A *
01/12/2009 Millennium Biotechnology, Inc. [ARCHIVED] New York District Office CGMP/QSR/Medical Devices/Adulterated N/A *
01/09/2009 South Beach Supplements [ARCHIVED] Florida District Office Labeling/False & Misleading Claims/New Drug N/A *
01/08/2009 Katies Seafood [ARCHIVED] Dallas District Office Seafood HACCP/GMP for Foods/Adulterated N/A *

 

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ICECI Warning Letters

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