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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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    2000 Warning Letters

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    * 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

     

    Posted on May 26, 2009

    Letter Issue Date Company Name Issuing Office Subject Close Out Date
    July 20, 2000 Universal Reagents Inc. Detroit District Office Current Good Manufacturing Practice for Blood & Blood Products/Plasmapheresis Facility N/A *
    July 20, 2000 National Healthcare Manufacturing Corp. Center for Devices and Radiological Health Quality System Regulation/Sterile Ophthalmic Orthopedic & Angiography Convenience Kits N/A *
    July 20, 2000 Danos & Curole Marine Contractors Inc. New Orleans District Office Interstate Conveyance Sanitation Regulations/Potable & Non-potable Water Hydrants N/A *
    July 20, 2000 Sea Fare Foods Inc. Detroit District Office Seafood Processing Regulations/HACCP N/A *
    July 20, 2000 Jonal Dairy Seattle District Office Food/Cattle N/A *
    July 20, 2000 Wee Sprouts Seattle District Office Current Good Manufacturing Practice in Manufacturing Packing or Holding Human Food/Sprouts N/A *
    July 19, 2000 Diagnostic Imaging Center of Wilshire Los Angeles District Office Mammography Standards N/A *
    July 19, 2000 Caremore Medical Management Los Angeles District Office Mammography Standards N/A *
    July 19, 2000 Sunshine Sprouts Seattle District Office Current Good Manufacturing Practice in Manufacturing Packing or Holding Human Food/Sprouts N/A *
    July 19, 2000 Caremore Medical Management Los Angeles District Office Mammography Standards N/A *
    July 19, 2000 Spadafora Joseph W. D.O. Center for Devices and Radiological Health Clinical Investigator N/A *
    July 19, 2000 Andrews David W. M.D. Center for Biologics Evaluation and Research Clinical Investigator N/A *
    July 19, 2000 Perfect Sprouts Seattle District Office Current Good Manufacturing Practice in Manufacturing Packing or Holding Human Food/Sprouts N/A *
    July 18, 2000 M. Kane's Fish Market Inc. San Francisco District Office Seafood Processing Regulations/HACCP N/A *
    July 18, 2000 A. N. Deringer New England District Office Fresh Swordfish/Entry Intact Pending N/A *
    July 18, 2000 Rose Michael R. M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
    July 18, 2000 Worldwide Sport Nutritional Supplements Inc. Center for Food Safety and Applied Nutrition Food Labeling N/A *
    July 14, 2000 Mr. Robert's Seafoods Seattle District Office Seafood Processing Regulations/HACCP N/A *
    July 14, 2000 Rhodia Inc. Atlanta District Office Current Good Manufacturing Practices/Active Pharmaceutical Ingredient N/A *
    July 14, 2000 National Biochemicals Corp. Cincinnati District Office Bulk Drug Repacking & Distribution Facility/Active Pharmaceutical Ingredients/Animal Drug N/A *
    July 13, 2000 Cirugia Peruana S.A.C. Center for Devices and Radiological Health Quality System Regulation/Steril Absorbable & Non-Absorbable Stainless Steel Sutures N/A *
    July 13, 2000 Pure Water Solutions Inc. New Orleans District Office Quality System Regulation/Water Purification Systems for Hemodialysis N/A *
    July 13, 2000 Team Distribution Inc. Florida District Office Seafood Processing Regulations/HACCP N/A *
    July 13, 2000 Bergen Institute of Medicine New Jersey District Office Mammography Standards N/A *
    July 13, 2000 Advanced Medical Imaging of Oswego County New York District Office Mammography Standards N/A *
    July 12, 2000 Kincaid Coach Lines Inc. Kansas City District Office Control of Communicable Diseases/Interstate Conveyance Sanitation N/A *
    July 12, 2000 Midstate Veterinary Services PLLC New York District Office Veterinary Clinic N/A *
    July 12, 2000 Dong Ling Sprouts and Produce Co. San Francisco District Office Insanitary Conditions N/A *
    July 12, 2000 Georgetown Veterinary Clinic New York District Office Veterinary Clinic N/A *
    July 12, 2000 Salton Inc. Center for Devices and Radiological Health Rejuvenique/Lacks Premarket Approval/Misbranded N/A *
    July 12, 2000 Dermal Tone Inc. Center for Devices and Radiological Health Dermal Tone/Lacks Premarket Approval/Misbranded N/A *
    July 11, 2000 Moses Lake Clinic Seattle District Office Mammography Standards N/A *
    July 11, 2000 Catalysis Corporation Florida District Office New Drug/Misbranded N/A *
    July 11, 2000 St. Mary Medical Center Seattle District Office Mammography Standards N/A *
    July 11, 2000 Chenango Memorial Hospital New York District Office Mammography Standards N/A *
    July 11, 2000 Irving Women's Imaging Center Dallas District Office Mammography Standards N/A *
    July 11, 2000 Chelsea Catering Dallas District Office Airling Catering Facility/Interstate Conveyance Sanitation N/A *
    July 11, 2000 Integrity Pharmaceutical Corporation Detroit District Office Good Manufacturing Practices for Finished Pharmaceuticals N/A *
    July 11, 2000 Products Carousel Inc. San Francisco District Office Choo-Hooves Pressed Sticks/Adulterated Food/Pet Foods Manufacturer N/A *
    July 10, 2000 Columbia Hospital Minneapolis District Office Mammography Standards N/A *
    July 10, 2000 City Smoked Fish Company Detroit District Office Seafood Processing Regulations/HACCP N/A *
    July 10, 2000 Barwick Crab Company Florida District Office Seafood Processing Regulations/HACCP N/A *
    July 10, 2000 AmeriPure Oyster Companies New Orleans District Office Oyster Products/Misbranded/Labeling N/A *
    July 07, 2000 Tri-County Veterinary Medicine LLC New York District Office Food/Cattle N/A *
    July 07, 2000 Summerland Seafood Inc. Florida District Office Seafood Processing Regulations/HACCP N/A *
    July 07, 2000 De Kleiman Olga Z. DRA. Center for Devices and Radiological Health Little Sentry Junior Infant Breathing Monitor/Lacks Premarket Approval N/A *
    July 07, 2000 CentraCare Clinic Minneapolis District Office Mammography Standards N/A *
    July 06, 2000 Bimeda Animal Health Inc. Kansas City District Office Invalid Veterinarian/Client/Patient Relationship N/A *
    July 06, 2000 Abbott Laboratories Inc. Center for Biologics Evaluation and Research GMPfor Finished Pharmaceuticals/Biological Establishment Licensing/Sterility N/A *
    July 06, 2000 Prowers Medical Center Dallas District Office Mammography Standards N/A *


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