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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
January 06, 2009 True Renewal Denver District Office Promotional Claims False & Misleading/New Drugs N/A *
January 06, 2009 Reproductive Medicine Associates of Michigan Detroit District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products N/A *
January 06, 2009 Hammill Manufacturing Company Cincinnati District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
January 06, 2009 Reproductive Medicine Associates of Michigan Detroit District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products N/A *
January 06, 2009 Woodge Inc. DBA Mr. Fish 1/6/09 Atlanta District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
January 06, 2009 US Lab Research, Inc. Cincinnati District Office Labeling/Promotional Claims False & Misleading/New Drug N/A *
January 05, 2009 BodySaver Florida District Office New Drug/Labeling/False & Misleading Claims/Misbranded N/A *
January 05, 2009 Vince's Shellfish Co Inc San Francisco District Office Seafood HACCP/Adulterated N/A *
January 05, 2009 Bodysaver, LLC 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) Regulations N/A *
January 05, 2009 Endsley Dairy Farm, LLC Detroit District Office Illegal Drug Residue N/A *
January 03, 2009 Spirtos, Nick M. MD Center for Drug Evaluation and Research Clinical Investigator N/A *



 

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