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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
December 30, 2004 Bozenkill Dairy Farm New York District Office Animals for Sale for Slaughter as Food/Adulterated N/A *
December 29, 2004 Medefil, Inc. Chicago District Office Quality System Regulation for Medical Devices/Adulterated N/A *
December 28, 2004 West Bay Seafood Co., Inc. San Francisco District Office Seafood HACCP/Adulterated N/A *
December 27, 2004 BioHorizons Implant Systems, Inc. New Orleans District Office CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated N/A *
December 23, 2004 Best Veterinary Solutions, Inc. Minneapolis District Office Labeling/Adulterated N/A *
December 23, 2004 Wingate Seafood, LLC Baltimore District Office Seafood HACCP/Adulterated N/A *
December 22, 2004 Advanced Sterilization Products Los Angeles District Office Good Manufacturing Practice Requirement for the Quality System Regulation/Adulterated N/A *
December 22, 2004 Huebner Farm Minneapolis District Office Extralabel Drug Use in Animals/Adulterated N/A *
December 22, 2004 Cyberonics, Inc. Dallas District Office CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated N/A *
December 21, 2004 Nelson Laboratories, Inc. Center for Devices and Radiological Health Good Laboratory Practices N/A *
December 21, 2004 N64 Neutraceutica Detroit District Office Labeling/False & Misleading Claims/Misbranded N/A *
December 21, 2004 Just Fabulous Pastries, Inc. Los Angeles District Office Good Manufacturing Practices for Food/Adulterated/Insanitary Conditions N/A *
December 21, 2004 Borawski, Lawrence A. Florida District Office Labeling/False & Misleading Claims/Misbranded N/A *
December 21, 2004 Euro-USA Trading Co., Inc. New England District Office Food Labeling/Misbranded N/A *
December 21, 2004 Denver Tofu Company, Inc. Denver District Office Labeling/Promotional Claims False & Misleading/Misbranded N/A *
December 20, 2004 Jessie's Ilwaco Fish Co, Inc. Seattle District Office Seafood HACCP/Adulterated N/A *
December 20, 2004 Respi Care Group of Puerto Rico San Juan District Office Unapproved New Drug/Adulterated/Misbranded N/A *
December 17, 2004 The Meat Market, Inc. San Francisco District Office Seafood HACCP/Adulterated N/A *
December 17, 2004 Galens Garden Center for Food Safety and Applied Nutrition Labeling/New Drug/False & Misleading Claims/Misbranded N/A *
December 17, 2004 Red River Pharmacy Services, Inc. Dallas District Office Active Pharmaceutical Ingredient/Adulterated N/A *



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ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857
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