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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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    2002 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 04, 2009

    Letter Issue Date Company Name Issuing Office Subject Close Out Date
    November 04, 2002 Breathe Easy Medical Equipment Cincinnati District Office CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished Pharmaceuticals/Adulterated N/A *
    November 04, 2002 Walgreen Company Chicago District Office New Drug (OTC) N/A *
    November 01, 2002 Lactroport USA Minneapolis District Office Cheeses and Related Cheese Products /Misbranded N/A *
    November 01, 2002 Miriam Santisteban Wysocki, M.D., Inc. Los Angeles District Office Mammography Quality Standards N/A *
    November 01, 2002 Presbyterian Healthcare Services Denver District Office Blood & Blood Products/Adulterated N/A *
    November 01, 2002 Diagnostic Imaging, Inc. New York District Office Performance Standard for Diagnostic X-ray Equipment N/A *
    November 01, 2002 Tysons Food, Inc New Orleans District Office Current Good Manufacturing Practice for Medicated Feeds/Adulterated N/A *
    November 01, 2002 Park Nicollet Health Systems Minneapolis District Office Mammography Quality Standards N/A *
    November 01, 2002 UPC Medical Supplies, Inc. Center for Devices and Radiological Health Lack Premarket Approval for Promotional Claims N/A *
    October 31, 2002 True World Foods, Inc. Dallas District Office Seafood HACCP N/A *
    October 31, 2002 Requeson Cruz-Pitre San Juan District Office Current Good Manufacuring Practice Reuirement for Food Manufacuring/Adulterated N/A *
    October 31, 2002 CIDEC Corporation New York District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
    October 31, 2002 General Electric Company-Medical System Dallas District Office Performance Standards for Diagnostic X-ray Equipment N/A *
    October 30, 2002 Heimann Systems Corporation Center for Devices and Radiological Health Safety Performance Standard for Cabinet X-ray Systems N/A *
    October 30, 2002 AP Diagnostic Imaging, Inc. New Jersey District Office Mammography Quality Standards N/A *
    October 30, 2002 Aqel, Raed, M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
    October 29, 2002 St. Aloisius Medical Center Minneapolis District Office Mammography Quality Standards N/A *
    October 29, 2002 Superior Seafoods, Inc. Detroit District Office Seafood HACCP/Adulterated N/A *
    October 29, 2002 Hurricane Seafood, Inc. Florida District Office Seafood HACCP/Adulterated N/A *
    October 29, 2002 Best Formulations Los Angeles District Office CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated N/A *
    October 28, 2002 Long Island Diagnostic Imaging New York District Office Mammography Quality Standards N/A *
    October 25, 2002 Cody, Kendall S. New York District Office Edible Tissue/Adulterated N/A *
    October 25, 2002 Becton Dickinson & Company San Juan District Office Quality System Regulation for Medical Devices/Labeling N/A *
    October 24, 2002 St. Joseph Medical Center Seattle District Office Mammography Quality Standards N/A *
    October 23, 2002 California Co-Packers LLC San Francisco District Office Seafood HACCP N/A *
    October 23, 2002 Bristol-Myers Squibb Manufacturing Company San Juan District Office CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated N/A *
    October 23, 2002 Tellez, Juan L., M.D. Center for Biologics Evaluation and Research Clinical Investigator N/A *
    October 23, 2002 Biomedical Implant Technology, Inc. Center for Devices and Radiological Health Quality System Reguation/Adulterated N/A *
    October 22, 2002 Santa Paula Memorial Hospital Los Angeles District Office Mammography Quality Standards N/A *
    October 22, 2002 Life Enchancement Products, Inc. Center for Drug Evaluation and Research Dietary Supplements/Labeling/Misbranded N/A *
    October 22, 2002 Beaver Dam Community Hospital Minneapolis District Office Mammography Quality Standards N/A *
    October 22, 2002 Good Samaritan Health Systems Kansas City District Office GMP for Blood & Blood Components/Records & Reports N/A *
    October 22, 2002 Swedish Fish Company Baltimore District Office Good Manufacturing Practices Regulations for Food/Seafood HACCP N/A *
    October 21, 2002 Pioneer Medical Group, Inc - Long Beach Los Angeles District Office Mammography Quality Standards N/A *
    October 21, 2002 Zincomatic, Inc. Denver District Office New Drug/Adulterated/Misbranded N/A *
    October 21, 2002 Wilbur-Ellis Company Denver District Office Food Additive Permitted in Feed, Drinking Water of Animals/Unsafe Food Additive/Adulterated N/A *
    October 21, 2002 Talbert Medical Group - Huntington Beach Los Angeles District Office Mammography Quality Standards N/A *
    October 18, 2002 Inland Seafood Atlanta District Office Seafood HACCP N/A *
    October 18, 2002 Health Care Manufacturing, Inc. Kansas City District Office Quality System Reguation/Adulterated N/A *
    October 18, 2002 Harford Memorial Hospital Baltimore District Office Mammography Quality Standards N/A *
    October 18, 2002 Unico Holdings, Inc. Florida District Office CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished Pharmaceuticals/Adulterated N/A *
    October 18, 2002 Hendersonville Gynecology & Obstetrics New Orleans District Office Mammography Quality Standards N/A *
    October 17, 2002 Drogueria Central San Juan District Office Drug Labeling/Misbranded N/A *
    October 17, 2002 Hanmi, Inc. Chicago District Office Seafood HACCP/CGMP Manufacturing, Packing or Holding Human Food/Adulterated N/A *
    October 17, 2002 Giliana & Huziran Chicago District Office Food Labeling/Misbranded N/A *
    October 17, 2002 International Gourmet Food Baltimore District Office Seafood HACCP N/A *
    October 16, 2002 Steinhatchee Fish Inc. Florida District Office Seafood HACCP/Adulterated N/A *
    October 16, 2002 D & D Catering Inc. Florida District Office Seafood HACCP/Adulterated N/A *
    October 15, 2002 Abbott Laboratories, Inc. Dallas District Office CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished Pharmaceuticals/Adulterated N/A *
    October 15, 2002 Jackson-Madison County General Hospital New Orleans District Office Mammography Quality Standards N/A *


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