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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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2004 Warning Letters

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Warning Letters issued in 2004

 

* 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
November 09, 2004 South Florida Medical Corporation Florida District Office CGMP for Oxygen/Manufacturing, processing, packing, storage & holding/Adulterated N/A *
November 09, 2004 Northern Implants L.L.C. Baltimore District Office CGMP/QSR/Medical Devices/Adulterated N/A *
November 09, 2004 Germiphene Corporation Center for Devices and Radiological Health CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated N/A *
November 08, 2004 Spandet Dairy, Inc. Dallas District Office Extralabel Drug Use in Animals/Adulterated N/A *
November 08, 2004 AMF Support Surfaces, Inc. Los Angeles District Office Lacks Approved Premarket Application/Adulterated N/A *
November 05, 2004 Synthes, Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Device Reporting/Adulterated N/A *
November 05, 2004 Purington, Timothy W. Center for Biologics Evaluation and Research Clinical Investigator N/A *
November 05, 2004 VitalCare Group, Inc. Florida District Office CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated N/A *
November 04, 2004 Kaiser Permanente Medical Center-Vallejo San Francisco District Office Mammography Quality Standards N/A *
November 03, 2004 Great Atlantic Trading Atlanta District Office Seafood HACCP/Adulterated N/A *
November 02, 2004 Rhody Dairy Seattle District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
November 02, 2004 Reid's Bus Service Kansas City District Office Interstate Conveyance Sanitation Regulations N/A *
November 02, 2004 Liko, Inc. New England District Office CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated N/A *
November 02, 2004 Blood Net USA, Inc. Florida District Office CGMP for Blood & Blood Components/Adulterated N/A *
November 01, 2004 ABC Compounding Company, Inc. Atlanta District Office Lacks Approved New Drug Application/Adulterated/Misbranded N/A *
November 01, 2004 Shin Chang Medical Co., Ltd. Center for Devices and Radiological Health CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated N/A *
October 29, 2004 VitalCare Group, Inc. Center for Devices and Radiological Health CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated N/A *
October 28, 2004 Henry, Gary Cincinnati District Office CGMP for Medicated Feeds/Unapproved New Animal Drug/Adulterated N/A *
October 27, 2004 Rick's Gulf Tex Seafood, Inc. Dallas District Office Seafood HACCP/Adulterated N/A *
October 26, 2004 Refrescos Lugo San Juan District Office Food Labeling/Misbranded N/A *



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ICECI Warning Letters

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