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Inspections, Compliance, Enforcement, and Criminal Investigations

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2000 Warning Letters

Warning Letters for 2000

Letter Issue Date Company Name Issuing Office Subject
December 29, 2000 true World Foods Inc. Denver District Office Seafood HACCP
December 29, 2000 House of Smoke Inc. Denver District Office Seafood HACCP/Adulterated
December 28, 2000 Fox Chase Cancer Center Philadelphia District Office Mammography Standards
December 28, 2000 Haribo of America Inc. Baltimore District Office Jellied Candy/Lacks
December 28, 2000 Fox Chase Cancer Center Philadelphia District Office Mammography Standards
December 27, 2000 Knox Hirons Chicago District Office Food/Cattle/Adulterated
December 27, 2000 Walquist Farm Chicago District Office Food/Cattle/Adulterated
December 27, 2000 Peche de Puerto Rico Inc. San Juan District Office Seafood Processing Regulations/HACCP
December 26, 2000 American Bio Medica Corporation Center for Devices and Radiological Health Rapid Drug Screen/Adulterated/Lacks Premarket Approval/Misbranded
December 22, 2000 East Palestine Family Medical Clinic Inc. Cincinnati District Office Mammography Standards
December 22, 2000 Advanced Health Care Minneapolis District Office Mammography Standards
December 22, 2000 Beverly Hills Diagnostic Breast Center Los Angeles District Office Mammography Standards
December 22, 2000 Spectrum Health Betty Ford Breast Care Services Detroit District Office Mammography Standards
December 21, 2000 Westerly Hospital New England District Office Mammography Standards
December 21, 2000 Washington Crab Company Inc. Atlanta District Office Seafood Processing Regulations/HACCP
December 21, 2000 P & L Schouten Dairy Dallas District Office Food/Cattle/Adulterated
December 21, 2000 St. Mary's Center for Women's Health Minneapolis District Office Mammography Standards
December 20, 2000 St. Mary's Gateway Health Center Minneapolis District Office Mammography Standards
December 20, 2000 Organon Teknika BV Center for Drug Evaluation and Research Postmarketing Adverse Drug Experience Reporting Requirements
December 20, 2000 Alexander Community Hospital Atlanta District Office Mammography Standards
December 20, 2000 Elcat Company New Orleans District Office Methamphetamine Hydrochloride/Active Pharmaceutcal Ingredients/Adulterated
December 20, 2000 Banco de Sangre Humacao Inc. San Juan District Office Good Manufacting Practices for Blood and Components
December 20, 2000 Top Katch Seafood Inc. Florida District Office Seafood Processing Regulations/HACCP
December 19, 2000 U.S. Food Service Inc. New England District Office Seafood Processing Regulations/HACCP
December 19, 2000 E.A. Conway Medical Center New Orleans District Office Mammography Standards
December 19, 2000 Kodiak Smoking and Processing Seattle District Office Seafood Processing Regulations/HACCP
December 19, 2000 Belford Seafood Co-Op New Jersey District Office Seafood Processing Regulations/HACCP
December 18, 2000 ADI Corporation Center for Devices and Radiological Health Television/Computer Monitor Factories/Automatic Detention
December 18, 2000 Blue Light Inc. New York District Office New Drug/Misbranded/Adulterated
December 18, 2000 Xinjiang Pharmaceutical Factory Center for Drug Evaluation and Research Active Pharmaceutical Ingredient Mfr Facility/Adulterated/Manufacturing Processing Packaging etc.
December 18, 2000 Coram Healthcare New Orleans District Office Liquid Medical Oxygen/Adulterated
December 18, 2000 Marukai Corporation San Francisco District Office Seafood Processing Regulations/HACCP
December 16, 2000 Missa Bay Inc. New Jersey District Office Seafood Processing Regulations/HACCP
December 15, 2000 Ultralite Enterprises Inc. Atlanta District Office Quality System Regulation/Phototherapy Units/Misbranded/MDR Reporting/Adulterated
December 15, 2000 C & J Seafood Inc. New Orleans District Office Seafood Processing Regulations/HACCP
December 15, 2000 Murex Diagnostics Inc. Center for Biologics Evaluation and Research Quality System Regulation
December 15, 2000 Ultralite Enterprises Inc. Atlanta District Office Quality System Regulation/Phototherapy Units/Adulterated
December 15, 2000 Upcountry Fishery Inc. San Francisco District Office Seafood Processing Regulations/HACCP
December 14, 2000 Genentech Inc. Center for Biologics Evaluation and Research Good Manufacturing Practices for Finished Pharmaceuticals/Biological Products General Provisions
December 14, 2000 Tianjin Xin Xin Pharmaceutical Corporation Center for Drug Evaluation and Research Active Pharmaceutical Ingredient/Adulterated/FMP's Manufacturing Processing Packing etc.
December 14, 2000 Airgas Norpac Seattle District Office Medical Gas/Adulterated
December 14, 2000 San Dimas Community Hospital Los Angeles District Office Mammography Standards
December 14, 2000 Intercoastal Medical Group Florida District Office Mammography Standards
December 13, 2000 Everett Clinic Seattle District Office Mammography Standards
December 12, 2000 University OB-GYN Specialties Inc. Cincinnati District Office Mammography Standards
December 12, 2000 Scholzen Products Company Inc. Denver District Office GMP for Finished Pharmaceuticals/Gas & Liquid Medical Oxygen/Adulterated
December 11, 2000 Radiology Clinics of Laredo Dallas District Office Mammography Standards
December 11, 2000 Leiner Health Products Inc. Atlanta District Office Good Manufacturing Practice for Finished Pharmaceuticals/Adulterated
December 11, 2000 Holy Cross Hospital Dallas District Office Mammography Standards
December 11, 2000 Chemrich Holdings Inc. Los Angeles District Office Manufacturing Facility/Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated
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