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2008 Warning Letters

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Warning Letters issued in 2008

 

* 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
November 13, 2008 Saudek, Christopher D., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
November 13, 2008 G.N.Y. Filet Fish Co., Inc. [ARCHIVED] New York District Office Seafood HACCP/GMP for Foods/Adulterated N/A *
November 13, 2008 Lam, Fred M.D. [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
November 12, 2008 John M. Mellott Farm [ARCHIVED] Philadelphia District Office Illegal Drug Residue N/A *
November 12, 2008 Steven's Pharmacy [ARCHIVED] Los Angeles District Office New Drug/Labeling/False & Misleading Claims N/A *
November 12, 2008 John Mellott Farm [ARCHIVED] Philadelphia District Office Illegal Drug Residue N/A *
November 07, 2008 Hai Soon Leong Sdn Bhd [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated N/A *
November 04, 2008 Innovative Neurotronic, Inc. [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated N/A *
November 03, 2008 Blue Ribbon Fish Co. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
November 03, 2008 Spacelabs Healthcare Incorporated [ARCHIVED] Seattle District Office CGMP/QSR/Medical Devices/Adulterated N/A *
October 31, 2008 Three Sister's Snacks Corporation [ARCHIVED] Minneapolis District Office Nutrition Labeling of Food/Misbranded N/A *
October 31, 2008 Caraco Pharmaceutical Laboratories, Ltd [ARCHIVED] Detroit District Office CGMP Deviations N/A *
October 31, 2008 Deltex Pharmaceuticals Inc [ARCHIVED] Dallas District Office CGMP/Otc Drug Products/Adulterated N/A *
October 31, 2008 PrimaPharm Inc. [ARCHIVED] Los Angeles District Office Unapproved New Drug/Adulterated/Misbranded N/A *
October 29, 2008 Aerosol Science Laboratories Inc. [ARCHIVED] Center for Drug Evaluation and Research False & Misleading Claims/New Drug/Misbranded N/A *
October 28, 2008 BioSafe America Corporation [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
October 27, 2008 Bayer HealthCare LLC [ARCHIVED] Center for Drug Evaluation and Research Drug Labeling/Promotional Claims/Misbranded N/A *
October 27, 2008 Bayer HealthCare LLC [ARCHIVED] Center for Drug Evaluation and Research Drug Labeling/Promotional Claims/Misbranded N/A *
October 24, 2008 IBA Molecular, Inc [ARCHIVED] Baltimore District Office Deviation/Adulterated N/A *
October 23, 2008 P East Trading Corporation [ARCHIVED] New York District Office Seafood HACCP/Adulterated N/A *



 

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