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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
January 14, 2009 Healthy Origins [ARCHIVED] Philadelphia District Office Labeling/False & Misleading Claims/New Drug/Misbranded N/A *
January 12, 2009 Millennium Biotechnology, Inc. [ARCHIVED] New York District Office CGMP/QSR/Medical Devices/Adulterated N/A *
January 09, 2009 South Beach Supplements [ARCHIVED] Florida District Office Labeling/False & Misleading Claims/New Drug N/A *
January 08, 2009 Katies Seafood [ARCHIVED] Dallas District Office Seafood HACCP/GMP for Foods/Adulterated N/A *
January 07, 2009 SSI Laser Engineering Inc [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
January 07, 2009 SSI Laser Engineering Inc [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
January 06, 2009 Woodge Inc. DBA Mr. Fish 1/6/09 [ARCHIVED] Atlanta District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
January 06, 2009 Food Joy Fresh Seafood, Inc. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
January 06, 2009 True Renewal [ARCHIVED] Denver District Office Promotional Claims False & Misleading/New Drugs N/A *
January 06, 2009 Reproductive Medicine Associates of Michigan [ARCHIVED] Detroit District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products N/A *
January 06, 2009 Hammill Manufacturing Company [ARCHIVED] Cincinnati District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
January 06, 2009 US Lab Research, Inc. [ARCHIVED] Cincinnati District Office Labeling/Promotional Claims False & Misleading/New Drug N/A *
January 06, 2009 Reproductive Medicine Associates of Michigan [ARCHIVED] Detroit District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products N/A *
January 05, 2009 BodySaver [ARCHIVED] Florida District Office New Drug/Labeling/False & Misleading Claims/Misbranded N/A *
January 05, 2009 BioReliance Corporation Center for Biologics Evaluation and Research Good Laboratory Practice (GLP) N/A *
January 05, 2009 Endsley Dairy Farm, LLC [ARCHIVED] Detroit District Office Illegal Drug Residue N/A *
January 05, 2009 Bodysaver, LLC [ARCHIVED] Florida District Office New Drug/Labeling/False & Misleading Claims/Misbranded N/A *
January 05, 2009 Vince's Shellfish Co Inc [ARCHIVED] San Francisco District Office Seafood HACCP/Adulterated N/A *
January 03, 2009 Spirtos, Nick M. MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *



 

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