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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
August 05, 2009 Schafer Fisheries, Inc. Chicago District Office Seafood HACCP/Adulterated N/A *
August 05, 2009 Bayer HealthCare - Bayer Schering Pharma AG Center for Drug Evaluation and Research CGMP for Deviations/Adulterated N/A *
July 31, 2009 Ion Labs, Inc. Florida District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded N/A *
July 31, 2009 G & H Dairy #1, LLC Seattle District Office Illegal Drug Residue N/A *
July 31, 2009 Byrne Medical, inc. Dallas District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
July 30, 2009 Synflex America Inc Florida District Office New Drug/Adulterated N/A *
July 30, 2009 Medical Accessories, Inc. New Jersey District Office CGMP/QSR/Medical Devices/Adulterated N/A *
July 30, 2009 American Bio Medica Corp Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
July 29, 2009 Tcmhelpme Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
July 28, 2009 Gadaleto's Seafood Market, Inc. New York District Office Seafood HACCP/GMP for Foods/Adulterated N/A *
July 27, 2009 Bodee LLC Los Angeles District Office Dietary Supplement/Labeling False and Misleading/Misbranded N/A *
July 27, 2009 Lucky Acres Philadelphia District Office Illegal Drug Residue N/A *
July 27, 2009 Harris, Barbara A Center for Drug Evaluation and Research Clinical Investigator N/A *
July 27, 2009 Americell-labs.com VMG Global Inc San Francisco District Office Dietary Supplements/Adulterated/Misbranded N/A *
July 24, 2009 ABL - Antibiotics Do Brasil Center for Drug Evaluation and Research CGMP/Adulterated N/A *
July 24, 2009 Hinsdale Farms, Ltd. Detroit District Office CGMP/Adulterated N/A *
July 23, 2009 Chris' Seafood New Orleans District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
July 23, 2009 Poly Packaging Systems, Inc. New Orleans District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
July 22, 2009 Q-Based Solutions Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
July 22, 2009 Ohio Medical Corporation Chicago District Office CGMP/QSR/Medical Device/Adulterated N/A *



 

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