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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
    February 17, 2000 Presbyterian Hospital of Winnsboro Dallas District Office Mammography Standards N/A *
    February 17, 2000 Gramercy Radiology Group P.C. New York District Office Mammography Standards N/A *
    February 17, 2000 Pharmaceutical Corporation of America Detroit District Office Drug Products/Repackaging Operations/CGMP N/A *
    February 17, 2000 Modesto Imaging Center Inc. San Francisco District Office Mammography Standards N/A *
    February 16, 2000 Muro Pharmaceutical Inc. New England District Office Finished Pharmaceuticals N/A *
    February 16, 2000 Seaview Radiology P.C. New York District Office Mammography Standards N/A *
    February 15, 2000 Doctor's Hospital - Tidwell Dallas District Office Mammography Standards N/A *
    February 15, 2000 Sirus Technology Corp. Center for Devices and Radiological Health Laser Product Performance Standard N/A *
    February 15, 2000 Porter Hospital Dallas District Office Mammography Standards N/A *
    February 14, 2000 TransOcean Maritime New Jersey District Office Potable Water Hydrants/Backflow Prevention Devices/Violations N/A *
    February 14, 2000 Baptist Medical Center Dallas District Office Mammography Standards N/A *
    February 14, 2000 HealthPartners Inc. Minneapolis District Office Mammography Standards N/A *
    February 14, 2000 Carlos C. Lourenco Dairy San Francisco District Office Food/Cattle N/A *
    February 14, 2000 Gloucester Refrigerated Warehouse New Jersey District Office Potable Water Hydrants/Backflow Prevention Devices/Violations N/A *
    February 14, 2000 St. Vincent Infirmary Medical center Dallas District Office Mammography Standards N/A *
    February 11, 2000 Women Care Minneapolis District Office Mammography Standards N/A *
    February 11, 2000 Individual Monitoring Systems Inc. Baltimore District Office Quality System Regulation/Electroencephalographs N/A *
    February 11, 2000 C & J Seafood and Crab Company Inc. New Orleans District Office Seafood Processing Regulations/HACCP N/A *
    February 10, 2000 Safety Diposal System Inc. Florida District Office Quality System Regulation/Reprocessing of Medical Devices (Reusable Sharps Containers) N/A *
    February 09, 2000 Encino-Tarzana Regional Medical Center Encino Hospital Los Angeles District Office Mammography Standards N/A *
    February 09, 2000 Steer Charles J. New Orleans District Office Food/Cattle N/A *
    February 08, 2000 Diagnotic X-ray and Imaging New York District Office Mammography Standards N/A *
    February 08, 2000 United Airlines San Francisco District Office Backflow Prevention Device N/A *
    February 08, 2000 LSG Sky Chef Inc. New York District Office Insanitary Conditions N/A *
    February 08, 2000 KaiserAir Inc. San Francisco District Office Airline Waste Service N/A *
    February 08, 2000 Willet Dairy LP New York District Office Food/Cattle N/A *
    February 08, 2000 University Hospitals Breast Center at Parkway Cincinnati District Office Mammography Standards N/A *
    February 08, 2000 Hyperbaric Technologies Incorporated Center for Devices and Radiological Health Hyperbaric Chambers/Premarket Clearance N/A *
    February 08, 2000 Central Minnesota Diagnostic Inc. -Mobile Minneapolis District Office Mammography Standards N/A *
    February 08, 2000 River Oaks East - Woman's Pavilion New Orleans District Office Mammography Standards N/A *
    February 07, 2000 Professionals for Womens Health Cincinnati District Office Mammography Standards N/A *
    February 07, 2000 American Pharmaceutical Partners Inc. Chicago District Office Pharmaceutical Manufacturing Facility/Finished Pharmaceutical Regulations/cGMP N/A *
    February 07, 2000 LR Plast A/S Center for Devices and Radiological Health Quality System Regulation/Contract Sterilizer Medical Devices N/A *
    February 07, 2000 Continental Transcargo Florida District Office Pharmaceuticals/Not Available for FDA Examination N/A *
    February 07, 2000 Spice Trader's International Inc. Florida District Office Sesame Seeds/Not Available for FDA Examination N/A *
    February 07, 2000 Hybrite Chemical Company Minneapolis District Office CGMP/Finished Pharmaceuticals N/A *
    February 07, 2000 Ashland Hopital Corporation Cincinnati District Office Medical Oxygen N/A *
    February 07, 2000 Vado Jorge Luis Florida District Office Foodstuffs & Cheese Shipment N/A *
    February 07, 2000 Hewlett Packard Company Florida District Office Color Monitors/Not Available for FDA Examination N/A *
    February 07, 2000 Abbott Laboratories Inc. Dallas District Office Quality System Regulation/Clinical Chemistry Analyzers N/A *
    February 04, 2000 Pharmacy Associates Incorporated Baltimore District Office Medical Gas Manufacturing Facility N/A *
    February 04, 2000 Breast Diagnostic Center Baltimore District Office Mammography Standards N/A *
    February 03, 2000 Numed Inc. New York District Office Quality System Regulation/Dilatation Catheters N/A *
    February 03, 2000 Pharmacia & Upjohn S.p.A. Center for Drug Evaluation and Research Current Good Manufacturing Practice in Manufacturing Packing or Holding Human Food/Adulterated N/A *
    February 03, 2000 Mogen Circumcision Instruments Ltd. New York District Office Quality System Regulation/Circumcision Clamps N/A *
    February 03, 2000 ENDO Surgical Concepts Inc. New England District Office Quality System Regulation/Sterile Bone Screws N/A *
    February 03, 2000 Franciscan Medicenter Cincinnati District Office Mammography Standards N/A *
    February 03, 2000 Miner's Colfax Medical Center Dallas District Office Mammography Standards N/A *
    February 02, 2000 Figaretti's Manufacturing and Distributing Baltimore District Office Good Manufacturing Practices for Food Processing/Acidified Foods N/A *
    February 02, 2000 Belmont Community Hospital Cincinnati District Office Mammography Standards N/A *


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