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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
December 18, 2002 Kraft Foods North America, Inc. Chicago District Office Food Standards/Cheese and Related Products/Misbranded N/A *
December 18, 2002 Greater Miami Caterers Inc. Florida District Office Seafood HACCP/Adulterated N/A *
December 17, 2002 Paul Ramer Construction Detroit District Office New Drug/Adulterated N/A *
December 17, 2002 Minneapolis Radiology Associates, Ltd. Minneapolis District Office Mammography Quality Standards N/A *
December 17, 2002 Eastern Medical Equipment Distributors, Inc. Florida District Office CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated N/A *
December 16, 2002 Gulf Medical Services Florida District Office CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated N/A *
December 13, 2002 VBM Medizintechnik GMBH Center for Devices and Radiological Health Quality System Regulation/Adulterated N/A *
December 12, 2002 Southern Herb Acquisition Co., LLC Minneapolis District Office New Drug/Misbranded N/A *
December 12, 2002 Primary Care Plus Atlanta District Office Mammography Quality Standards N/A *
December 12, 2002 Land O'Lakes Kansas City District Office Extralabel Drug Use in Animals/Adulterated N/A *
December 11, 2002 Y & L Washington, Inc. Seattle District Office Seafood HACCP/Food Labeling/Adulterated/Misbranded N/A *
December 11, 2002 Virginia Seafood, LLC Baltimore District Office Food Labeling/Misbranded N/A *
December 11, 2002 Beaumont Products, Inc. Atlanta District Office Unapproved New Drug/GMP for Finished Pharmaceuticals/Misbranded N/A *
December 11, 2002 VISX Inc Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
December 11, 2002 Metropolitan Hospital Center New York District Office Mammography Quality Standards N/A *
December 10, 2002 Superior Uniform Group, Inc. Dallas District Office QSR/Lack Premarket Approval/Registration Listing/Adulterated/Misbranded N/A *
December 10, 2002 Serv-A-Pure Company Detroit District Office Quality System Regulation/Water Purification Systems/Adulterated N/A *
December 09, 2002 E.M. Adams Co., Inc. Florida District Office Quality System Reguation/Adulterated N/A *
December 09, 2002 Catholic Health Partners Center for Biologics Evaluation and Research IRB (Institutional Review Board) N/A *
December 06, 2002 E & M Corp San Francisco District Office Food Labeling/Misbranded N/A *



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ICECI Warning Letters

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Food and Drug Administration

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Rockville, MD 20857
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