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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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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 18, 2002 Inland Seafood Atlanta District Office Seafood HACCP 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 Jackson-Madison County General Hospital New Orleans District Office Mammography Quality Standards N/A *
October 15, 2002 The Outer Banks Hospital Atlanta District Office Mammography Quality Standards 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 Ports Seafood, Inc. San Francisco District Office Seafood HACCP/Adulterated N/A *
October 11, 2002 Duramed Pharmceuticals Inc. Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Goldline Laboratories Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 PDRX Pharmaceuticals Inc. Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 United Research Laboratories Inc. Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Sidmak Laboratories Inc. Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Heartland Repack Services LLC Center for Drug Evaluation and Research Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Vangard Labs Inc. Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Halsey Drug Co Inc. Center for Drug Evaluation and Research Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin N/A *



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ICECI Warning Letters

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