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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2004 Warning Letters

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Warning Letters issued in 2004

 

* 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
March 26, 2004 Genesis Nutrition Center for Food Safety and Applied Nutrition Dietary Supplement Lableing/False & Misleading Claims/Misbranded N/A *
March 25, 2004 Chuter, Timothy A.M., M.D. Center for Devices and Radiological Health Sponsor/Clinical Investigator N/A *
March 25, 2004 Reisman, Mark, M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
March 25, 2004 Anti Aging Solutions Inc. Center for Devices and Radiological Health Lacks Marketing Approval/Misbranded/Adulterated N/A *
March 25, 2004 Abbott Laboratories, Inc. Chicago District Office Quality System Regulation/Adulterated N/A *
March 25, 2004 Siems, Jon L., M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
March 24, 2004 Quality Meats & Seafood, Inc. Minneapolis District Office Seafood HACCP/Adulterated N/A *
March 24, 2004 Encore, Inc. Florida District Office QSR/Lacks Premarket Approval Application/Adulterated/Misbranded N/A *
March 23, 2004 Consolidated Chemical, Inc. Kansas City District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
March 23, 2004 Michigan Instruments, Inc. Detroit District Office Quality System Regulations for Medical Devices/Adulterated N/A *
March 22, 2004 Medical Measurements, Inc. New Jersey District Office Quality System Regulation/Medical Device Reporting/Adulterated/Misbranded N/A *
March 22, 2004 Dreamland, Inc. Seattle District Office Food Labeling/Misbranded N/A *
March 19, 2004 Interstate Baking Corp. New York District Office Food Labeling/Misbranded N/A *
March 18, 2004 Sousa Lobster Co., Inc. New England District Office Seafood HACCP/Adulterated N/A *
March 17, 2004 Hillcrest Dairy, LLC San Francisco District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
March 16, 2004 Tennessee Cheesecake Company New Orleans District Office Food Labeling/Misbranded N/A *
March 16, 2004 Maxim's Import Corporation Florida District Office Seafood HACCP/Adulterated N/A *
March 15, 2004 Louisville Regional Airport Authority Cincinnati District Office Interstate Conveyance Sanitation N/A *
March 15, 2004 Statz Farms & Sons Minneapolis District Office Illegal Drug Residue Animal Tissue/Extra-Label Drug Use/Adulterated N/A *
March 12, 2004 Processors, Inc. New Orleans District Office Seafood HACCP/Adulterated N/A *



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ICECI Warning Letters

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