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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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    1998 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
    December 30, 1998 A.W. Curtis Pharmaceuticals Inc. New York District Office Drug Product/Rubbing Oil N/A *
    December 29, 1998 Harold Food Company Atlanta District Office Insanitary Conditions N/A *
    December 29, 1998 CeramOptec Inc. Center for Devices and Radiological Health Laser Product Performance Standard N/A *
    December 29, 1998 Robert Bugatto Enterprises Inc. dba The Tides Wharf San Francisco District Office Seafood Processing Regulations/HACCP N/A *
    December 24, 1998 Ganes Chemicals Inc. New Jersey District Office Equipment Cleaning Valisation/Microbial Specifications/Purity Stability Testing N/A *
    December 24, 1998 Sonogage Inc. Cincinnati District Office Devices/Corneo Gage Ultrasonic Pachometer N/A *
    December 23, 1998 Ginsberg's Institutional Foods Inc. New York District Office Seafood Processing Regulations/HACCP N/A *
    December 23, 1998 Kaha Import Detroit District Office Food Drinks N/A *
    December 23, 1998 American Airlines Inc. Dallas District Office CFR Deviations N/A *
    December 23, 1998 Ocean State Lobster LLC New England District Office Seafood Processing Regulations/HACCP N/A *
    December 23, 1998 Yater Medical Group Baltimore District Office Mammography Standards N/A *
    December 23, 1998 Sun Belt Trading Inc. Los Angeles District Office Food Additive/Ammoniated Cottonseed N/A *
    December 22, 1998 Weikert's Livestock Inc. Philadelphia District Office Food/Cattle N/A *
    December 22, 1998 McNichol's Dead and Crippled Livestock Philadelphia District Office Food/Cattle N/A *
    December 22, 1998 Mercer Livestock Auction Inc. Philadelphia District Office Food/Cattle N/A *
    December 22, 1998 Southeast Crab Company Inc. New Orleans District Office Seafood Processing Regulations N/A *
    December 21, 1998 Syfrett Feed Company Inc. Florida District Office Medicated Feeds N/A *
    December 21, 1998 Pinecrest Jersey Farm San Francisco District Office Food/Cattle N/A *
    December 21, 1998 Captain Bob's Seafood Philadelphia District Office Seafood Processing Regulations/HACCP N/A *
    December 18, 1998 Atos Medical AB Center for Devices and Radiological Health Good Manufacturing Practices Violations N/A *
    December 18, 1998 Labtician Ophthalmics Center for Devices and Radiological Health Good Manufacturing Practices Violations N/A *
    December 18, 1998 American Eagle New York District Office CFR Deviations N/A *
    December 18, 1998 SeraCare Acquisitions Inc. Seattle District Office Blood Products N/A *
    December 18, 1998 International Medical Inc. Florida District Office Quality System Regulations / Medical Devices N/A *
    December 18, 1998 Scottcare Corporation Inc. Cincinnati District Office N/A *
    December 18, 1998 Dentek-Lasersystems Produktions Ges.m.b.H. Center for Devices and Radiological Health Laser Product Performance Standard N/A *
    December 18, 1998 Evergreen Mills Inc. Dallas District Office Medicated Feeds N/A *
    December 18, 1998 Novartis AG Center for Drug Evaluation and Research Postmarketing Adverse Drug Experience N/A *
    December 17, 1998 Johnson Donald E. M.D. Center for Drug Evaluation and Research Clinical Investigator N/A *
    December 17, 1998 Duesch?r Hilltop Jerseys Minneapolis District Office Food/Cattle N/A *
    December 17, 1998 Advanced Vision Research New England District Office Labeling/Eye Drops N/A *
    December 16, 1998 Reliv International Inc. Kansas City District Office Drug Products/Labeling N/A *
    December 16, 1998 Virjo Seafood Inc. Florida District Office Seafood Processing Regulations/HACCP N/A *
    December 16, 1998 Sherwood Brands Inc. New York District Office Federal Food Drug and Cosmetic Act Violations N/A *
    December 15, 1998 Catfish Wholesale Inc. New Orleans District Office Food/Sanitation N/A *
    December 14, 1998 Boston Electtrodomestici S.r.l. Center for Devices and Radiological Health Laser Products / Noncompliance N/A *
    December 14, 1998 Knoll Pharmaceutical Co. New Jersey District Office CGMP/Finished Pharmaceuticals N/A *
    December 11, 1998 Diasonics Ultrasound Inc. San Francisco District Office Devices/Ultrasound Probes N/A *
    December 11, 1998 Control System Internation Inc. Kansas City District Office Devices/Shotwave Diathermy Device N/A *
    December 11, 1998 Schneider's Fish & Seafood Corp. New York District Office Seafood Processing Regulations/HACCP N/A *
    December 11, 1998 Lincare Inc. New York District Office Medical Oxygen N/A *
    December 11, 1998 Mayer's Brothers Apple Products Inc. New York District Office Food/Apple Products N/A *
    December 11, 1998 Dade Behring AG Center for Biologics Evaluation and Research CFR Deviations N/A *
    December 10, 1998 Sweet 'n' Spicy Foods Incorporated Baltimore District Office Insanitary Conditions N/A *
    December 10, 1998 Freed's Pharmacy Inc. Kansas City District Office Medical Oxygen N/A *
    December 10, 1998 Carmo Dairy San Francisco District Office Food/Cattle N/A *
    December 10, 1998 Falls Chemical Products Inc. Minneapolis District Office Veterinary Drugs N/A *
    December 09, 1998 Welcon Inc. New England District Office Devices N/A *
    December 09, 1998 Smith Welding Supply Detroit District Office Medical Oxygen N/A *
    December 08, 1998 Consumer Product Testing Company New Jersey District Office CGMP Deviations N/A *


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