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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2002 Warning Letters

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Warning Letters for 2002

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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

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
October 28, 2002 Long Island Diagnostic Imaging New York District Office Mammography Quality Standards N/A *
October 25, 2002 Becton Dickinson & Company San Juan District Office Quality System Regulation for Medical Devices/Labeling N/A *
October 25, 2002 Cody, Kendall S. New York District Office Edible Tissue/Adulterated N/A *
October 24, 2002 St. Joseph Medical Center Seattle District Office Mammography Quality Standards 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 California Co-Packers LLC San Francisco District Office Seafood HACCP 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 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 Life Enchancement Products, Inc. Center for Drug Evaluation and Research Dietary Supplements/Labeling/Misbranded N/A *
October 22, 2002 Santa Paula Memorial Hospital Los Angeles District Office Mammography Quality Standards 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 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 21, 2002 Zincomatic, Inc. Denver District Office New Drug/Adulterated/Misbranded N/A *
October 18, 2002 Harford Memorial Hospital Baltimore District Office Mammography Quality Standards N/A *
October 18, 2002 Health Care Manufacturing, Inc. Kansas City District Office Quality System Reguation/Adulterated 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 *



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ICECI Warning Letters

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