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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
    November 29, 2000 L.V. Stabler Hospital New Orleans District Office Mammography Standards N/A *
    November 29, 2000 Republic Drug Company New York District Office Good Manufacturing Practices/Finished Pharmaceuticals/Mfring Processing Packing etc/Adulterated N/A *
    November 29, 2000 Perpective International Florida District Office Laser Surgical Instrument/Lacks "May Proceed Notice" or "Release Notice" N/A *
    November 28, 2000 Atlanta Oriental Food Wholesale Co. Atlanta District Office Seafood Processing Regulations/HACCP N/A *
    November 28, 2000 Sweet Valley Inc. San Juan District Office Food Labeling/Gelatin and Vanilla Custard Products N/A *
    November 28, 2000 Brumfield Enterprises Inc. Cincinnati District Office Food Labeling/Graeter's Famous French Pot Ice Cream/Misbranded N/A *
    November 28, 2000 Metro Imaging Dallas District Office Mammography Standards N/A *
    November 28, 2000 Services Support Inc. Center for Devices and Radiological Health Rife Technology Products/Adulterated/Lacks Premarket Approval/Misbranded N/A *
    November 28, 2000 Naviera Coffee Mills Florida District Office Finished Coffee Products/Misbranded N/A *
    November 28, 2000 Croma Vision Medical Systems Incorporated Center for Devices and Radiological Health ACIS/Clinical Claims/Misbranded/Adulterated/Premarket Notification Procedure N/A *
    November 28, 2000 Abadir Associates Center for Devices and Radiological Health AdatoSil 5000/Misbranded/Adulterated/Lacks Premarket Approval N/A *
    November 28, 2000 Hubert H. Humphrey Comprehensive Health Center Los Angeles District Office Mammography Standards N/A *
    November 27, 2000 Kern Valley Healthcare District San Francisco District Office Mammography Standards N/A *
    November 27, 2000 Kahuku Hospital San Francisco District Office Mammography Standards N/A *
    November 27, 2000 Sid Peterson Memorial Hospital Dallas District Office Mammography Standards N/A *
    November 27, 2000 Linder Quann Medical Group San Francisco District Office Mammography Standards N/A *
    November 27, 2000 Sutter North Medical Foundation San Francisco District Office Mammography Standards N/A *
    November 27, 2000 Faith Regional Health Services-East Campus-Mobile Dallas District Office Mammography Standards N/A *
    November 27, 2000 Sutter North Medical Foundation San Francisco District Office Mammography Standards N/A *
    November 27, 2000 Comprehensive Medical Imaging - Bakersfield San Francisco District Office Mammography Standards N/A *
    November 22, 2000 Bryan Medical Group Inc. Cincinnati District Office Mammography Standards N/A *
    November 22, 2000 Respicare Home Respiratory and Medical Seattle District Office Oxygen Repacking Facility/CGMP/Adulterated N/A *
    November 22, 2000 Pavich Family Farms Center for Food Safety and Applied Nutrition Pavich Brand Organic Crimson Seedless Grapes/Misbranded/Labeling N/A *
    November 22, 2000 Eaton Rapids Medical Center Detroit District Office Mammography Standards N/A *
    November 22, 2000 Vernon Memorial Hopital Minneapolis District Office Mammography Standards N/A *
    November 22, 2000 Saunders Provision Co. Inc. Baltimore District Office Food Warehouse/Insanitary Conditions/Food Products/Adulterated N/A *
    November 22, 2000 Dilenttante Chocolates Inc. Seattle District Office Kristopher Chocolate Santa/Food Labeling/Misbranded N/A *
    November 22, 2000 Community Memorial Hospital Detroit District Office Mammography Standards N/A *
    November 21, 2000 Bates Jersey Corporation New Jersey District Office Medical Oxygen/Adulterated/Misbranded N/A *
    November 21, 2000 J. W. Reyneveld Dairy Farm Inc. San Francisco District Office Food/Cattle/Adulterated N/A *
    November 21, 2000 Tony DeGroot Dairy San Francisco District Office Food/Cattle/Adulterated N/A *
    November 21, 2000 SOL Pharmaceuticals Limeited Center for Drug Evaluation and Research Good Manufacturing Practices for Active Pharmaceutical Ingredient N/A *
    November 21, 2000 Miranda Livestock San Francisco District Office Food/Cattle/Adulterated N/A *
    November 21, 2000 Thomas Crab Company New Orleans District Office Seafood Processing Regulations/HACCP N/A *
    November 21, 2000 Alton Ochsner Medical Foundation Blood Bank New Orleans District Office Blood & Blood Components N/A *
    November 20, 2000 Prosser Memorial Hospital Seattle District Office Mammography Standards N/A *
    November 20, 2000 Jefferson General Hospital Seattle District Office Mammography Standards N/A *
    November 20, 2000 Holzer Medical Center Cincinnati District Office Mammography Standards N/A *
    November 20, 2000 Luther L. Smith & Son Inc. Atlanta District Office Seafood Processing Regulations/HACCP N/A *
    November 20, 2000 C&C Home Care Inc. New York District Office Medical Oxygen/Adulterated N/A *
    November 17, 2000 Deli Inc. Baltimore District Office Seafood Processing Regulations/HACCP N/A *
    November 17, 2000 Moroni Feed Company Denver District Office Current Good Manufacturing Practice Regulations for Medicated Feeds/Adulterated N/A *
    November 17, 2000 Medix Pharmaceuticals Americas Inc. Florida District Office Quality System Regulation/Derma Freeze Ethyl Chloride USP/Misbranded N/A *
    November 17, 2000 Associates of Cape Cod Inc. Center for Biologics Evaluation and Research Quality System Regulation N/A *
    November 17, 2000 Watts Health Foundation Inc. Los Angeles District Office Mammography Standards N/A *
    November 17, 2000 Scripps Clinic San Diego Los Angeles District Office Mammography Standards N/A *
    November 17, 2000 Alcon Laboratories Inc. Dallas District Office Quality System Regulation/Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
    November 17, 2000 Northside Radiology New Orleans District Office Mammography Standards N/A *
    November 17, 2000 Baxter Health Care Florida District Office Pumps (Components)/Lacks N/A *
    November 17, 2000 Galley Food Services Inc. New York District Office Airline Catering Facility N/A *


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