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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
    January 14, 2000 Barr John D. M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
    January 14, 2000 Morton Grove Pharmaceuticals Inc. Chicago District Office Drug Products / CGMP N/A *
    January 13, 2000 Quality Seafood Atlanta District Office Seafood Processing Regulations/HACCP N/A *
    January 13, 2000 Gilster-Mary Lee Corporation Chicago District Office Kroger Baking Mix/Adultered/Labeling/Misbranded N/A *
    January 13, 2000 Gary Watson Dairy Dallas District Office Food/Cattle N/A *
    January 12, 2000 L & W Group Inc. San Francisco District Office Seafood Processing Regulations/HACCP N/A *
    January 12, 2000 Camino Medical Group San Francisco District Office Mammography Standards N/A *
    January 12, 2000 Advanced Restoration Technologies Inc. Denver District Office New Drug Listing/Misbranded N/A *
    January 12, 2000 Wha Soon Trading Company San Francisco District Office Seafood Shipment/Fish Maw/Labeling/Misrepresentation N/A *
    January 11, 2000 Fradama S.A. Center for Devices and Radiological Health Laser Product Performance Standard N/A *
    January 10, 2000 Good Samaritan Hospital Chicago District Office Blood Bank/Standard Operating Procedures N/A *
    January 10, 2000 Procesadora Campofresco Inc. San Juan District Office Food Labeling/Juice Products N/A *
    January 07, 2000 Tom H. Piatt M.D. Inc. San Francisco District Office Mammography Standards N/A *
    January 07, 2000 Fruit Fillings Inc. San Francisco District Office Labeling/Misbranded N/A *
    January 07, 2000 Tender Corporation Inc. New England District Office OTC Drug Manufacturing Facility/cGMP N/A *
    January 07, 2000 James Alexander Corporation New Jersey District Office Current Good Manufacturing Practice N/A *
    January 07, 2000 Presby Corp. Center for Devices and Radiological Health Sponsor Obligations N/A *
    January 07, 2000 LeBlanc's Cajun Boudin & Food Company Inc. New Orleans District Office Seafood Processing Regulations/HACCP N/A *
    January 07, 2000 Bennett Medical Services San Francisco District Office Medical Oxygen N/A *
    January 07, 2000 Supreme Juice Company Chicago District Office Food Labeling/Fruit Joy Blue Rasberry Drink N/A *
    January 07, 2000 Lahey Clinic New England District Office Mammography Standards N/A *
    January 06, 2000 Kaelbel Wholesale Inc. Florida District Office Seafood Processing Regulations/HACCP N/A *
    January 06, 2000 Visions in Endosurgery Inc. Inc. Florida District Office Quality System Regulation/Medical Devices Reprocessing N/A *
    January 06, 2000 Cascade Dairy San Francisco District Office Food/Cattle N/A *
    January 06, 2000 Ansell Perry de Mexico SA de CV Center for Devices and Radiological Health Devices/Examination Gloves N/A *
    January 06, 2000 North Fork Radiology P.C. New York District Office Mammography Standards N/A *
    January 05, 2000 Reznik Instrument Inc. Chicago District Office Quality System Regulaion/Trocars & Surgical Instruments N/A *
    January 05, 2000 Upper Valley Family Care Cincinnati District Office Mammography Standards N/A *
    January 05, 2000 Selma District Hospital San Francisco District Office Mammography Standards N/A *
    January 05, 2000 Vitrophage Inc. Chicago District Office Quality System Regulation/Intraocular Fluid N/A *
    January 04, 2000 Obstetrics & Gynecology Providers Inc. Cincinnati District Office Mammography Standards N/A *
    January 04, 2000 PAL Laboratories Inc. Florida District Office OTC Drug Repackager/Good Manufacturing Practices N/A *
    January 04, 2000 Lake Success Imaging New York District Office Mammography Standards N/A *
    January 03, 2000 Hanover Foods New Jersey District Office Seafood Processing Regulations/HACCP N/A *
    January 03, 2000 Leisegang Medical Inc. Center for Devices and Radiological Health Laser Product Performance Standard N/A *
    January 03, 2000 World Trade Foods Florida District Office Seafood Processing Regulations/HACCP N/A *
    January 03, 2000 William Bee Ririe Hospital San Francisco District Office Mammography Standards N/A *
    January 03, 2000 Valley State Prison For Women San Francisco District Office Mammography Standards N/A *


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