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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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    2001 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 20, 2001 Bryan Enterprises Cincinnati District Office Feed Mill/Animal Proteins Prohibited in Ruminant Feed/Adulterated N/A *
    February 16, 2001 Sidney Hillman Medical Center Philadelphia District Office Mammography Quality Standards N/A *
    February 15, 2001 Micro Worldwide Trading Florida District Office Animal Antibiotic/Lacks "May Proceed Notice" or "Release Notice" N/A *
    February 15, 2001 Lubar Seafood Corporation Florida District Office Marlin Loins Shipment/Lacks "May Proceed Notice" or "Release Notice" N/A *
    February 15, 2001 Greensward Nurseries San Francisco District Office Insanitary Conditions/Raw Sprouts/Adulterated N/A *
    February 15, 2001 J-Lloyd Medical Inc. New Jersey District Office Quality System Regulation/Cardiac Balloon-Catheters/Adulterated N/A *
    February 15, 2001 Gulf City Seafoods Inc. New Orleans District Office Seafood Processing Regulations/HACCP N/A *
    February 15, 2001 Felix Custom Smoking Seattle District Office Seafood Processing Regulations/HACCP N/A *
    February 15, 2001 Dakota Clinic Ltd. Minneapolis District Office Mammography Standards N/A *
    February 14, 2001 Reynolds Health Center Atlanta District Office Mammography Standards N/A *
    February 14, 2001 Long Island Radiology Associates P. C. New York District Office Mammography Standards N/A *
    February 13, 2001 Cryogenic Medical Gases Denver District Office Medical Oxygen/Adulterated N/A *
    February 13, 2001 Schwan's Sales Enterprises Manufacturing Inc. Dallas District Office Seafood Processing Regulations/HACCP N/A *
    February 13, 2001 Missouri Baptist Medical Center-Mobile Dallas District Office Mammography Standards N/A *
    February 12, 2001 Howard County General Hospital Baltimore District Office Mammography Standards N/A *
    February 12, 2001 Nubenco Enterprises Inc. New Jersey District Office HIV 1 + 2 Test Kits/Lacks Premarket Approval/Export Regulations/Listing Requirements/Adulterated N/A *
    February 12, 2001 Long Island Jewish Radiology Private Practice New York District Office Mammography Standards N/A *
    February 12, 2001 Beranbaum Khilnani Neistadt Jacobs Hertz & Sherman MDs P.C. New York District Office Mammography Standards N/A *
    February 12, 2001 Women Care Minneapolis District Office Mammography Standards N/A *
    February 12, 2001 Continental Airlines Baltimore District Office Interstate Conveyance Sanitation Regulations N/A *
    February 12, 2001 Gel Spice Company Inc. New York District Office Brazilian Black Pepper/Not Held Intact N/A *
    February 12, 2001 Beloit Memorial Hospital Minneapolis District Office Mammography Standards N/A *
    February 12, 2001 UW Health/West Clinic Minneapolis District Office Mammography Standards N/A *
    February 12, 2001 Basik Swift & Determined Cincinnati District Office Veterinary Syringes/Not Held Intact for Inspection/Import N/A *
    February 12, 2001 Bioray Inc. Center for Devices and Radiological Health Lacks Premarket Approval/Not Substantially Equivalent/Misbranded/Adulterated N/A *
    February 12, 2001 Log Haven Dairy San Francisco District Office Food/Cattle/Adulterated N/A *
    February 12, 2001 Frank Chaves & Sons Dairy San Francisco District Office Food/Cattle/Adulterated N/A *
    February 12, 2001 Carlos Seafood Incorporated Florida District Office Seafood Processing Regulations/HACCP N/A *
    February 12, 2001 Optilux Florida District Office Contact Lenses/Lacks "May Proceed Notice" or "Release Notice" N/A *
    February 12, 2001 University of Kansas Dallas District Office Mammography Standards N/A *
    February 09, 2001 CoPharma Inc. Office of Enforcement GMP of Manufacturing of Bulk Products/Adulterated N/A *
    February 09, 2001 Perstrop Specialty Chemicals AB Center for Devices and Radiological Health Quality System Regulation/Gels Pads & Powders with Iodine/Adulterated N/A *
    February 09, 2001 Medical Diagnostic Imaging Detroit District Office Mammography Standards N/A *
    February 09, 2001 Ferraris Medical Ltd. Center for Devices and Radiological Health Quality System Regulation/Respirometers and Peak Flow Meters/Adulterated N/A *
    February 09, 2001 Kingman Regional Medical Center Los Angeles District Office Unlicensed Blood Band & Transfusion Service/Adulterated N/A *
    February 09, 2001 Lifesigns Inc. New Orleans District Office Mammography Standards N/A *
    February 09, 2001 Merck & Co. Inc. Office of Enforcement GMP for Finished Pharmaceuticals/Biologics Licensing N/A *
    February 09, 2001 Curtin Dairy LP New York District Office Food/Cattle/Adulterated N/A *
    February 08, 2001 Cangene Corporation Center for Biologics Evaluation and Research GMP for Finished Products/Biologics/Establishment Licensing N/A *
    February 08, 2001 LifeSource Blood Services Chicago District Office Good Manufacturing Practice Regulations for Blood and Blood Components N/A *
    February 07, 2001 Royal Farms Dairy LLC Kansas City District Office Food/Cattle/Adulterated N/A *
    February 07, 2001 Boyd-Bluford Inc. Baltimore District Office Insanitary Conditions/Food Storage Warehouse/Adulterated N/A *
    February 07, 2001 Docheff Dairy Denver District Office Dairy/Adulterated/Illegal Drug Residue N/A *
    February 06, 2001 Jeby Enterprises Florida District Office Carbonated Beverages/Lacks "May Proceed Notice" or "Release Notice" N/A *
    February 06, 2001 Vandyk Dairy Seattle District Office New Animal Drug/Adulterated N/A *
    February 06, 2001 Craig Hessenius Farm Chicago District Office Food/Cattle/Adulterated N/A *
    February 06, 2001 Jonal Bakery LTD Chicago District Office Numerous Insanitary Conditions N/A *
    February 06, 2001 Hummermeier Farm Chicago District Office Food/Cattle/Adulterated N/A *
    February 06, 2001 Donley Farms Inc. Seattle District Office New Animal Drug/Adulterated N/A *
    February 05, 2001 Cornerstone Dairy San Francisco District Office Food/Cattle/Adulterated N/A *


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