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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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2001 Warning Letters

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Warning Letters for 2001

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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 12, 2001 Mese Hsin Tung Yang Foods, Inc. San Francisco District Office Seafood HACCP N/A *
October 12, 2001 Fair Scones, Inc. Seattle District Office Food Labeling/Adulterated/Misbranded N/A *
October 11, 2001 China Farms Detroit District Office GMP in Manufacturing, Packing, Holding Human Food/Insanitary Conditions/Adulterated N/A *
October 11, 2001 Carmel's Seafood New Orleans District Office Current Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated N/A *
October 11, 2001 Guangzhou Yue Xiu Enterprise/Danby Products, Inc. Center for Devices and Radiological Health Performance Standards for Electronic Products/Microwave & Radio Frequency Emitting Product N/A *
October 11, 2001 Coulston Foundation Center for Drug Evaluation and Research GLP (Good Laboratory Practices) N/A *
October 11, 2001 Pine Ridge Reservation Comprehensive Health Center Minneapolis District Office Mammography Quality Standards N/A *
October 11, 2001 Ellsworth Air Force Base Minneapolis District Office Mammography Quality Standards N/A *
October 10, 2001 Reel Food Service, Inc. Seattle District Office Seafood HACCP N/A *
October 10, 2001 Pier Fish Company New England District Office Seafood HACCP N/A *
October 10, 2001 Lian Hwa Foods (U.S.A), Inc. San Francisco District Office Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated N/A *
October 10, 2001 Reel Food Service, Inc. Seattle District Office Seafood HACCP N/A *
October 10, 2001 Unique Pharmaceuticals, Ltd. Dallas District Office GMP for Finished Pharmaceuticals/Manufacture & Distribution/Adulterated/Misbranded N/A *
October 09, 2001 Wright Whitty Davis Farms Inc Atlanta District Office Animals for Sale for Slaughter as Food/Adulterated N/A *
October 09, 2001 Chase Medical, Inc. Dallas District Office CGMP Requirements of the Quality System Regulations/Adulterated/Misbranded N/A *
October 09, 2001 Ultra Tan, Inc. San Francisco District Office Federal Performance Standard for Sunlamp Products/Misbranded N/A *
October 09, 2001 Vitatech International, Inc. Los Angeles District Office CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished Pharmaceuticals/Adulterated N/A *
October 09, 2001 PMT Coporation Minneapolis District Office Quality System Regulation for Medical Devices/Adulterated N/A *
October 09, 2001 Loyola Dairy Los Angeles District Office Illegal Drug Tissue Residue/Adulterated N/A *
October 09, 2001 Ultra Tan, Inc. San Francisco District Office Federal Performance Standard for Sunlamp Products/Misbranded N/A *



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ICECI Warning Letters

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