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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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    Warning Letters for 2000

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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
    March 15, 2000 Signature Flight Support Baltimore District Office Interstate Conveyance Sanitation Regulation Deficiencies N/A *
    March 15, 2000 Genesist Inc. Denver District Office Amino Acid/Dietary Supplements/Labeling N/A *
    March 15, 2000 Medical Associates of Gallipolis Inc. Cincinnati District Office Mammography Standards N/A *
    March 15, 2000 Radiology Diagnostic Center Los Angeles District Office Mammography Standards N/A *
    March 14, 2000 Newport Seafoods Inc. Seattle District Office Seafood Processing Regulations/HACCP N/A *
    March 14, 2000 Bales Scientific Inc. Center for Devices and Radiological Health Thermal Image Processor Photonic Stimulator/Lacks Premarket Approval/Promotional Claims N/A *
    March 14, 2000 Jenkins Community Hospital Cincinnati District Office Mammography Standards N/A *
    March 14, 2000 Pacific Coast Medical Services Los Angeles District Office Mammography Standards N/A *
    March 14, 2000 University of Utah Health Network - Mt. Ogden Center Dallas District Office Mammography Standards N/A *
    March 14, 2000 Kim Yeongcheol M.D. New York District Office Mammography Standards N/A *
    March 14, 2000 Wyoming Medical Center Dallas District Office Mammography Standards N/A *
    March 13, 2000 Tri-City Outpatient Imaging Los Angeles District Office Mammography Standards N/A *
    March 13, 2000 McKinley Medical LLLP Denver District Office Quality System Regulations/Infusion Pumps & Infusion Tubing Sets N/A *
    March 13, 2000 Safe Harbor Seafood Inc. Florida District Office Seafood Processing Regulations/HACCP N/A *
    March 13, 2000 Green Mountain Smoked Salmon Seattle District Office Seafood Processing Regulations/HACCP N/A *
    March 13, 2000 Ponderosa Dairy San Francisco District Office Food/Cattle N/A *
    March 13, 2000 Spiess Design Inc. Chicago District Office Quality System Regulation/Endoscopes & Bipolar Forceps N/A *
    March 13, 2000 Frank J. Gomes Dairy San Francisco District Office Food/Cattle N/A *
    March 10, 2000 Center Laboratories Inc. Office of Enforcement GMP for Mfr Processing Packing Holding Drugs/Reporting Biological Products Deviations N/A *
    March 10, 2000 PrimeCare Medical Group Los Angeles District Office Mammography Standards N/A *
    March 10, 2000 Clinica Medica General - Huntington Park Los Angeles District Office Mammography Standards N/A *
    March 10, 2000 Thoratec Laboratories Corporation San Francisco District Office Quality System Regulation/Thoratec Ventricular Assist Device System N/A *
    March 10, 2000 Clinica Medica General - East L.A. Los Angeles District Office Mammography Standards N/A *
    March 10, 2000 KPC Medical Management Inc. Los Angeles District Office Mammography Standards N/A *
    March 09, 2000 Florida Smoked Fish Co. Philadelphia District Office Seafood Processing Regulations/HACCP N/A *
    March 09, 2000 Home Care Medical Equipment Inc. Nashville District Office Medical Oxygen / CGMP N/A *
    March 09, 2000 Greer Laboratories Inc. Center for Biologics Evaluation and Research Allergenic Extract/Finished Pharmaceuticals/Manufacturing/Holding & Processing N/A *
    March 09, 2000 Blue & White Food Products Corp. New York District Office Seafood Processing Regulations/HACCP N/A *
    March 09, 2000 Great Lakes College of Clinical Medicine IRB Center for Biologics Evaluation and Research IRB (Institutional Review Board) N/A *
    March 09, 2000 MedNet Services Inc. Minneapolis District Office Quality System Regulation/Interferential Nerve & Muscle Stimulator Device N/A *
    March 09, 2000 Celletech Ltd. Minneapolis District Office Tetanus/LM1 Nux Vomica & Udder Symptom/Lacks Premarket Approval/Misbranding N/A *
    March 08, 2000 Back To Nature Inc. Chicago District Office Dietary Supplements/Labeling/Misbranded N/A *
    March 08, 2000 Oxygen Therapy Institute Detroit District Office Berman Resusi CPR Mask/Lacks Premarket Approval N/A *
    March 08, 2000 Schell John E. New York District Office Food/Cattle N/A *
    March 08, 2000 New York Medical Group P.C. New York District Office Mammography Standards N/A *
    March 08, 2000 Carenet Medical Group New York District Office Mammography Standards N/A *
    March 08, 2000 Select Fish L.L.C. Seattle District Office Seafood Processing Regulations/HACCP N/A *
    March 08, 2000 Complete Home Care Equipment Inc. Nashville District Office Medical Oxygen N/A *
    March 07, 2000 Johnson Matthey Inc. New Jersey District Office CGMP/Active Pharmaceutical Ingredients N/A *
    March 07, 2000 Walton Medical Center Atlanta District Office Mammography Standards N/A *
    March 07, 2000 Med Cross Imaging Center Atlanta District Office Mammography Standards N/A *
    March 07, 2000 Med-Scan - Flint Detroit District Office Mammography Standards N/A *
    March 06, 2000 IMI of Miami Florida District Office Mammography Standards N/A *
    March 06, 2000 Early Detection Project Mobile Van Number 2 Florida District Office Mammography Standards N/A *
    March 06, 2000 Superior Seafood Inc. Detroit District Office Seafood Processing Regulations/HACCP N/A *
    March 06, 2000 Gourm-E-Co Imports New York District Office Imported Cheese/Not Held for Inspection N/A *
    March 06, 2000 Landauer Hospital Supplies Inc. New York District Office Medical Oxygen N/A *
    March 06, 2000 Peachtree City Gynecology Center Atlanta District Office Mammography Standards N/A *
    March 06, 2000 Riverside Imaging Center Florida District Office Mammography Standards N/A *
    March 06, 2000 Watson Clinic - Diagnostic Breast Center Florida District Office Mammography Standards N/A *


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