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

 

Posted on May 04, 2009

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	Wingate Seafood, LLC	Baltimore District Office	Seafood HACCP/Adulterated	N/A *
December 23, 2004	Best Veterinary Solutions, Inc.	Minneapolis District Office	Labeling/Adulterated	N/A *
December 22, 2004	Huebner Farm	Minneapolis District Office	Extralabel Drug Use in Animals/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	Cyberonics, Inc.	Dallas District Office	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	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	Denver Tofu Company, Inc.	Denver District Office	Labeling/Promotional Claims False & Misleading/Misbranded	N/A *
December 21, 2004	Nelson Laboratories, Inc.	Center for Devices and Radiological Health	Good Laboratory Practices	N/A *
December 21, 2004	Euro-USA Trading Co., Inc.	New England District Office	Food Labeling/Misbranded	N/A *
December 21, 2004	N64 Neutraceutica	Detroit District Office	Labeling/False & Misleading Claims/Misbranded	N/A *
December 21, 2004	Borawski, Lawrence A.	Florida District Office	Labeling/False & Misleading Claims/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	U R Farms	Seattle District Office	Extralabel Drug Use in Animals/Adulterated	N/A *
December 17, 2004	The Meat Market, Inc.	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
December 17, 2004	Red River Pharmacy Services, Inc.	Dallas District Office	Active Pharmaceutical Ingredient/Adulterated	N/A *

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