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Inspections, Compliance, Enforcement, and Criminal Investigations

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2002 Warning Letters

Warning Letters for 2002

Letter Issue Date Company Name Issuing Office Subject
December 30, 2002 Vukman, Gerald R., D.V.M. New York District Office Illegal Tissue Residue/Extralabel Drug Use in Animals/Adulterated
December 30, 2002 Swan River Fish Market New England District Office Seafood HACCP/Adulterated
December 30, 2002 Reyncrest Farms, Inc. New York District Office Extralabel Drug Use in Animals/Adulterated
December 28, 2002 Diamond Pacific Los Angeles District Office CGMP for Licensed Medicated Feeds/Adulterated
December 27, 2002 Fischer Imaging Corporation Denver District Office Quality System Regulation/Good Manufacturing Practice for Medical Devices/Adulterated
December 27, 2002 Searle, Ltd. San Juan District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated
December 26, 2002 Boersma #2 Dairy Los Angeles District Office Illegal Edible Tissue Residue/Adulterated
December 24, 2002 William M. Vargulick Dairy Farm New York District Office Illegal Drug Residue/Adulterated
December 24, 2002 Hoover Feed Service, Inc. Detroit District Office New Drug/Adulterated
December 23, 2002 Gambardella Wholesale Fish Dealers, Inc. New England District Office Seafood HACCP/Adulterated
December 23, 2002 DBA Zacharias Holsteins New England District Office Drug in Edible Tissue/Extralabel Use/Adulterated
December 20, 2002 McAnally Enterprises LLC Los Angeles District Office CGMP for Licensed Medicated Feeds/Adulterated
December 20, 2002 Wallach Surgical Devices, Inc. New England District Office CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated
December 20, 2002 Sunnyvale Seafood Corporation San Francisco District Office Seafood HACCP/Adulterated
December 20, 2002 Edward W. McCready Memorial Hospital Baltimore District Office Mammography Quality Standards
December 19, 2002 Coulter Corporation Office of Enforcement GMP for Blood and Blood Products/Quality System Regulation
December 19, 2002 Costa View Farms San Francisco District Office Illegal Edible Tissue Residue/Adulterated
December 19, 2002 Southwest Pharmacy/DBA Anchor Home Care New Orleans District Office CGMP/Oxygen Compressed/Adulterated
December 18, 2002 Vet Pharm, Inc. Kansas City District Office Extralabel Drug Use in Animals/Adulterated
December 18, 2002 Kraft Foods North America, Inc. Chicago District Office Food Standards/Cheese and Related Products/Misbranded
December 18, 2002 Greater Miami Caterers Inc. Florida District Office Seafood HACCP/Adulterated
December 18, 2002 Gateway Blood Association Kansas City District Office Blood Products/Lacks Approved License for Interstate Commerce
December 17, 2002 Minneapolis Radiology Associates, Ltd. Minneapolis District Office Mammography Quality Standards
December 17, 2002 Eastern Medical Equipment Distributors, Inc. Florida District Office CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated
December 17, 2002 Paul Ramer Construction Detroit District Office New Drug/Adulterated
December 16, 2002 Gulf Medical Services Florida District Office CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated
December 13, 2002 VBM Medizintechnik GMBH Center for Devices and Radiological Health Quality System Regulation/Adulterated
December 12, 2002 Southern Herb Acquisition Co., LLC Minneapolis District Office New Drug/Misbranded
December 12, 2002 Primary Care Plus Atlanta District Office Mammography Quality Standards
December 12, 2002 Land O'Lakes Kansas City District Office Extralabel Drug Use in Animals/Adulterated
December 11, 2002 VISX Inc Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated
December 11, 2002 Y & L Washington, Inc. Seattle District Office Seafood HACCP/Food Labeling/Adulterated/Misbranded
December 11, 2002 Virginia Seafood, LLC Baltimore District Office Food Labeling/Misbranded
December 11, 2002 Metropolitan Hospital Center New York District Office Mammography Quality Standards
December 11, 2002 Beaumont Products, Inc. Atlanta District Office Unapproved New Drug/GMP for Finished Pharmaceuticals/Misbranded
December 10, 2002 Serv-A-Pure Company Detroit District Office Quality System Regulation/Water Purification Systems/Adulterated
December 10, 2002 Superior Uniform Group, Inc. Dallas District Office QSR/Lack Premarket Approval/Registration Listing/Adulterated/Misbranded
December 09, 2002 Catholic Health Partners Center for Biologics Evaluation and Research IRB (Institutional Review Board)
December 09, 2002 E.M. Adams Co., Inc. Florida District Office Quality System Reguation/Adulterated
December 06, 2002 E & M Corp San Francisco District Office Food Labeling/Misbranded
December 06, 2002 Carib Import & Export, Inc. Florida District Office Seafood HACCP
December 06, 2002 Walk, William M. Chicago District Office Edible Tissue/Adulterated
December 06, 2002 Hobart Laboratories, Inc. Chicago District Office CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished Pharmaceuticals/Adulterated
December 05, 2002 Desert Advanced Imaging Center Los Angeles District Office Mammography Quality Standards
December 04, 2002 D.L. Mathews & Co. Inc. New Jersey District Office Seafood HACCP/Adulterated
December 03, 2002 Medical Diagnostic Center (Southside) Florida District Office Mammography Quality Standards
December 03, 2002 Classic Medical, Inc. Detroit District Office Medical Oxygen/CGMP for Finished Pharmaceuticals/Adulterated/Misbranded
December 03, 2002 Herbal Remedies USA, LLC Denver District Office New Drugs/Misbranded
December 02, 2002 Charles L. Earsing Dairy Farm New York District Office Illegal Tissue Residue/Extra-label Use/Adulterated
December 02, 2002 Hoogendam Dairy San Francisco District Office Illegal Drug Tissue Residue/Adulterated
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