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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
01/07/2009 SSI Laser Engineering Inc [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
01/07/2009 SSI Laser Engineering Inc [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
01/06/2009 Woodge Inc. DBA Mr. Fish 1/6/09 [ARCHIVED] Atlanta District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
01/06/2009 Food Joy Fresh Seafood, Inc. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
01/06/2009 True Renewal [ARCHIVED] Denver District Office Promotional Claims False & Misleading/New Drugs N/A *
01/06/2009 Reproductive Medicine Associates of Michigan [ARCHIVED] Detroit District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products N/A *
01/06/2009 Hammill Manufacturing Company [ARCHIVED] Cincinnati District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
01/06/2009 US Lab Research, Inc. [ARCHIVED] Cincinnati District Office Labeling/Promotional Claims False & Misleading/New Drug N/A *
01/06/2009 Reproductive Medicine Associates of Michigan [ARCHIVED] Detroit District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products N/A *
01/05/2009 BodySaver [ARCHIVED] Florida District Office New Drug/Labeling/False & Misleading Claims/Misbranded N/A *
01/05/2009 BioReliance Corporation Center for Biologics Evaluation and Research Good Laboratory Practice (GLP) N/A *
01/05/2009 Endsley Dairy Farm, LLC [ARCHIVED] Detroit District Office Illegal Drug Residue N/A *
01/05/2009 Bodysaver, LLC [ARCHIVED] Florida District Office New Drug/Labeling/False & Misleading Claims/Misbranded N/A *
01/05/2009 Vince's Shellfish Co Inc [ARCHIVED] San Francisco District Office Seafood HACCP/Adulterated N/A *
01/03/2009 Spirtos, Nick M. MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *

 

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ICECI Warning Letters

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Food and Drug Administration

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