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Inspections, Compliance, Enforcement, and Criminal Investigations

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2001 Warning Letters

Warning Letters for 2001

Letter Issue Date Company Name Issuing Office Subject
December 31, 2001 Matthews, Dana C., M.D. Center for Biologics Evaluation and Research Sponsor/Clinical Investigator
December 28, 2001 Green Gold Wholesale Produce Inc. Baltimore District Office Avocados/Lacks
December 28, 2001 Hen-Lin Dairy Minneapolis District Office Animal Drug/Adulterated
December 28, 2001 Trotters Importers Baltimore District Office Dried Fig Spread/Lacks
December 27, 2001 Premium Fresh Juice and Food Company, Inc. Los Angeles District Office GMP in Manufacturing, Packing, Holding Human Food/Insanitary Practices
December 27, 2001 B.N.S Uni, Inc. Los Angeles District Office Seafood HACCP
December 27, 2001 N TECH Instrument Repair, Inc. Chicago District Office Quality System Regulation for Medical Devices/Adulterated
December 27, 2001 2-2-0 Laboratories Los Angeles District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated
December 27, 2001 Island Kinetics Inc Los Angeles District Office CGMP for Finished Pharmaceutical/Adulterated
December 21, 2001 West Agro, Inc. Chicago District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated
December 21, 2001 Feldman Mark H. D.P.M. Center for Devices and Radiological Health Clinical Investigator
December 21, 2001 Forever Young Products, Inc. New Orleans District Office Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals
December 20, 2001 Breast Cancer Detection Center of Alaska Seattle District Office Mammography Quality Standards
December 20, 2001 NCOIC Dallas District Office Mammography Quality Standards
December 20, 2001 Port Bolivar Fisheries, Inc. Dallas District Office Seafood HACCP
December 20, 2001 Medical Center at Lancaster Dallas District Office Mammography Quality Standards
December 20, 2001 Carolina Seafood Ventures, LLC Atlanta District Office Seafood HACCP
December 20, 2001 Luskin-Hawk, M.D., Roberta L Center for Biologics Evaluation and Research Clinical Investigator
December 20, 2001 Misonix, Inc. Denver District Office GMP Requirements for the Quality System Regulation/Adulterated
December 20, 2001 Norton Suburban Hospital Cincinnati District Office Mammography Quality Standards
December 20, 2001 Van de Graaf Racnhes, Inc. Seattle District Office Current Good Manufacturing Practice for Medicated Feeds/Adulterated
December 19, 2001 Conklin Enterprises, Inc. Atlanta District Office Seafood HACCP
December 19, 2001 The Medical Group New Orleans District Office Mammography Quality Standards
December 19, 2001 Wayzata Bay Products Inc Minneapolis District Office Good Manufacturing Practice for Finished Pharmaceuticals/Adulterated
December 19, 2001 King's Oriental Foods Company Seattle District Office GMP for Manufacturing, Packing, Holding Food/Seafood HACCP
December 19, 2001 Diagnostic Medical Imaging Associates Cincinnati District Office Mammography Quality Standards
December 19, 2001 Jensen Tuna, Inc. New Orleans District Office Seafood HACCP
December 18, 2001 Multidata Systems International Corporation Center for Devices and Radiological Health Electronic Product Radiation Control/Premarket Notification Requirements/Adulterated/Misbranded
December 18, 2001 Michigan Trading Post Dallas District Office Food Labeling/NexCite Dietary Supplement/Misbranded
December 18, 2001 Atlantic General Hospital Baltimore District Office Mammography Quality Standards Act
December 18, 2001 Community Radiology Inc. Cincinnati District Office Mammography Quality Standards
December 17, 2001 Sibley Medical Associates Baltimore District Office Mammography Quality Standards
December 17, 2001 Carl & Don Frazier, Inc. Detroit District Office Seafood HACCP
December 17, 2001 King's Fish Market, Inc. Detroit District Office Current Good Manufacturing Pratice Requirements for Foods/Seafood HACCP
December 17, 2001 Women's Diagnostic Imaging Center Seattle District Office Mammography Quality Standards
December 17, 2001 Camtrade Enterprises, Inc. San Francisco District Office Good Manufacturing Practice Requirement for Foods/Seafood HACCP/Adulterated
December 14, 2001 Trusted Care New England District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated
December 14, 2001 Natural Technology, Inc. Dallas District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated
December 14, 2001 Rowan Animal Clinic Atlanta District Office Illegal Drug Residue/Adulterated
December 14, 2001 Shelly Smith Farm Atlanta District Office Illegal Drug Residue/Adulterated
December 14, 2001 Van Haitsma Dairy Farm Detroit District Office Illegal Drug Tissue Residue/Adulterated
December 14, 2001 Biorem s.r.l. Center for Devices and Radiological Health Medical Device/Lacks Premarket Approval/Adulterated/Misbranded
December 14, 2001 Trilogy Crab Company, Inc. Seattle District Office Seafood HACCP/Adulterated
December 14, 2001 Bollinger Quick Repair, Inc. New Orleans District Office Interstate Conveyance Sanitation Regulations
December 13, 2001 Dextrum Laboratories Inc Florida District Office CGMP for Drugs/Manufacture Processing Packing Holding/Adulterated
December 13, 2001 Cal-Maine Foods, Inc. New Orleans District Office Current Good Manufacturing Practice for Medicated Feeds/Adulterated
December 13, 2001 Providence Milwaukie Hospital Seattle District Office Mammography Quality Standards
December 13, 2001 Medical Device Services, Inc. Denver District Office Quality System/Good Manufacturing Practice for Medical Devices/Adulterated
December 13, 2001 Kittery Lobster Co., Inc. New England District Office Seafood HACCP
December 13, 2001 Rose Breast Center Dallas District Office Mammography Quality Standards
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