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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
April 16, 2004 Case Western Reserve University Center for Devices and Radiological Health Good Laboratory Practices N/A *
April 16, 2004 Canam Medsource Ltd Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
April 15, 2004 Gano Excel U.S.A. Inc. Los Angeles District Office Unapproved New Drug Promotional Claims/Misbranded N/A *
April 15, 2004 IsoComforter Inc Florida District Office CGMP/QSR/Manufacture/Packing/Storage/Installation N/A *
April 15, 2004 Premium Nutritional Products, Inc. Kansas City District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded N/A *
April 14, 2004 Peekay International Inc New York District Office Candy/misbranded/adulterated N/A *
April 14, 2004 Tidy View Dairy, Inc. Minneapolis District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
April 14, 2004 Computron Display Systems, Inc. Chicago District Office Quality System Regulation/Adulterated N/A *
April 14, 2004 Yoli, Inc. Chicago District Office Seafood HACCP/Adulterated N/A *
April 13, 2004 Florida Fisheries Enterprises, Inc. Florida District Office Seafood HACCP/Adulterated N/A *
April 12, 2004 Texas Orthopaedic Products & Services, LLC Dallas District Office QSR/Lacks Approved Premarket Application/Misbranded/Adulterated N/A *
April 12, 2004 Meredith-Warner Animal Clinic New Orleans District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
April 12, 2004 Knott Wholesale Foods New Orleans District Office Seafood HACCP/Adulterated N/A *
April 09, 2004 S & M Farm Supply Baltimore District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded N/A *
April 09, 2004 Sebastien and Marie Seafood, Inc. Florida District Office Seafood HACCP/Adulterated N/A *
April 09, 2004 Pyng Medical Corporation Center for Devices and Radiological Health Medical Device Reporting/Misbranded N/A *
April 09, 2004 Ciocca Dairy Seattle District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
April 08, 2004 Halter Feed & Grain, Inc. Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded N/A *
April 08, 2004 Bardstown Mill, Inc. Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded N/A *
April 08, 2004 Bo Wah Enterprises, Inc. San Francisco District Office Seafood HACCP/Adulterated N/A *



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ICECI Warning Letters

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