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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 29, 2009 Degrave, Dale and Peggy Minneapolis District Office Illegal Drug Residue N/A *
January 28, 2009 Cyclotron Center of NE Florida Florida District Office Deviation/Adulterated N/A *
January 27, 2009 D & D Hawkins Minneapolis District Office Illegal Drug Residue N/A *
January 27, 2009 Amedica Corporation Center for Devices and Radiological Health Premarket Approval/Adulterated N/A *
January 26, 2009 First Season, Inc Chicago District Office Seafood HACCP/Adulterated N/A *
January 26, 2009 Cannon Fish Company Seattle District Office Seafood HACCP/Adulterated N/A *
January 23, 2009 Mainline Technology, Inc Detroit District Office CGMP/QSR/Medical Devices/Adulterated N/A *
January 22, 2009 Sage Products Inc Chicago District Office CGMP Manufacturer, Processsing, Packing, Holding Drugs/Devices/Adulterated N/A *
January 21, 2009 Stewart, Lynette D. M.D Center for Drug Evaluation and Research Clinical Investigator N/A *
January 20, 2009 Nidek Medical Products Inc New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
January 15, 2009 Haelan Products Seattle District Office Promotional Claims False & Misleading/New Drug/Misbranded N/A *
January 15, 2009 Portland Shellfish Company, Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
January 14, 2009 Healthy Origins Philadelphia District Office Labeling/False & Misleading Claims/New Drug/Misbranded N/A *
January 14, 2009 Brewer, George J. M.D. Center for Drug Evaluation and Research Clinical Investigator N/A *
January 12, 2009 Millennium Biotechnology, Inc. New York District Office CGMP/QSR/Medical Devices/Adulterated N/A *
January 09, 2009 South Beach Supplements Florida District Office Labeling/False & Misleading Claims/New Drug N/A *
January 08, 2009 Katies Seafood Dallas District Office Seafood HACCP/GMP for Foods/Adulterated N/A *
January 07, 2009 SSI Laser Engineering Inc New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
January 07, 2009 SSI Laser Engineering Inc New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
January 06, 2009 Food Joy Fresh Seafood, Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *



 

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ICECI Warning Letters

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