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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
January 14, 2002 Aspen Medical Group Minneapolis District Office Mammography Quality Standards N/A *
January 14, 2002 Cottage Hospital New England District Office Mammography Quality Standards N/A *
January 14, 2002 Bachem California, Inc Los Angeles District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
January 14, 2002 Short Line Bus Company New York District Office Control of Communicable Disease and Interstate Conveyance Sanitation N/A *
January 09, 2002 Opti-Med Controlled Release Labs, Inc. Detroit District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
January 09, 2002 SeraCare Acquisitions, Inc. Kansas City District Office Good Manufacturing Practices for Blood & Blood Components/Adulterated N/A *
January 09, 2002 Magnet of Palm Beach, LTD Florida District Office Mammography Quality Standards N/A *
January 08, 2002 Mason General Hospital Seattle District Office Mammography Quality Standards N/A *
January 08, 2002 Middle East Bakery, Inc. New England District Office Food Labeling/Misbranded N/A *
January 08, 2002 Regional Diagnostic Imaging Center Florida District Office Mammography Quality Standards N/A *
January 08, 2002 Vos Dairy, Inc. Seattle District Office New Animal Drug/Tissue Sample/Adulterated N/A *
January 07, 2002 American Agco Corporation Minneapolis District Office Current Good Manufacturing Practice for Medicated Feeds/Adulterated N/A *
January 04, 2002 Gretchen of Schwartz Seattle District Office Seafood HACCP N/A *
January 04, 2002 Tony Crab King, Inc. New York District Office Seafood HACCP N/A *
January 03, 2002 Khouri, George G., M.D., PA Florida District Office Premarket Approval/Misbranded N/A *
January 03, 2002 Xavier Enterprise/Xavier Exotic Herbs Denver District Office New Drug/Misbranded N/A *
January 03, 2002 Pharmaceutical Distribution Systems Baltimore District Office CGMP for Finished Pharmaceutical/Adulterated N/A *
January 03, 2002 Farmsoy Company New Orleans District Office Food Labeling/Misbranded N/A *
January 02, 2002 Boscobel Area Health Care Minneapolis District Office Mammography Quality Standards N/A *
January 02, 2002 Chediak, Juan, M.D. Center for Biologics Evaluation and Research Clinical Investigator N/A *



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ICECI Warning Letters

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