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 *
December 17, 2004	Galens Garden	Center for Food Safety and Applied Nutrition	Labeling/New Drug/False & Misleading Claims/Misbranded	N/A *
December 15, 2004	Parker Foods, LLC	Los Angeles District Office	Seafood HACCP/Adulterated	N/A *
December 15, 2004	Precision Piece Parts, Inc.	Detroit District Office	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	N/A *
December 15, 2004	Roxy Trading, Inc.	Los Angeles District Office	Seafood HACCP/Adulterated	N/A *
December 15, 2004	Prime Veal Feed, Ltd.	Cincinnati District Office	Extralabel Drug Use in Animals/Misbranded	N/A *
December 15, 2004	Kling, Mitchel A., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
December 15, 2004	White Egret Farm	Dallas District Office	Control of Communicable Disease	N/A *
December 15, 2004	Nolan Livestock	Minneapolis District Office	Extralabel Drug Use in Animals/Adulterated	N/A *
December 14, 2004	TODDS	Los Angeles District Office	Seafood HACCP/Adulterated	N/A *
December 14, 2004	Kinton, Inc.	New Jersey District Office	Seafood HACCP/Adulterated	N/A *
December 14, 2004	Nature's Way Products, Inc.	Denver District Office	Food/Adulterated	N/A *
December 14, 2004	Gourmet Kitchen, Inc.	New Jersey District Office	CGMP for Foods/Seafood HACCP/Adulterated	N/A *
December 14, 2004	Can-x Products	Minneapolis District Office	Lacks New Drug Approval /Misbranded	N/A *
December 10, 2004	Jean's Greens	New York District Office	Labeling/Promotional Claims False & Misleading/Misbranded	N/A *
December 10, 2004	The Sanapac Co., Inc.	Philadelphia District Office	Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded	N/A *
December 10, 2004	Collins, Tyrone J., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
December 09, 2004	Lincare, Inc.	New Orleans District Office	Pharmacy Compounding/Misbranded	N/A *
December 09, 2004	Sunshine Mills, Inc.	New Orleans District Office	Animal Proteins Prohibited in Ruminant Feed/Misbranded	N/A *
December 09, 2004	Chiron Corporation	Office of Enforcement	CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated	N/A *
December 09, 2004	Danlee Medical Products, Inc.	New York District Office	Quality System Regulation for Medical Devices/Adulterated/Misbranded	N/A *
December 08, 2004	Veterinary Enterprises of Tomorrow, Inc.	Dallas District Office	Active Pharmaceutical Ingredient/Adulterated	N/A *
December 08, 2004	Lamar Seafood Corporation	Florida District Office	Seafood HACCP/Adulterated	N/A *
December 08, 2004	Continental Caviar	New Orleans District Office	Seafood HACCP/Adulterated/Misbranded	N/A *
December 07, 2004	Lex, Inc.	Florida District Office	CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated/Misbranded	N/A *
December 07, 2004	Goya Foods, Inc.	New Jersey District Office	Labeling/False & Misleading Claims/Adulterated/Misbranded	N/A *
December 06, 2004	Weyand Fisheries, Inc.	Detroit District Office	Seafood HACCP/Adulterated	N/A *
December 06, 2004	California Natural Products	San Francisco District Office	Low-Acid Foods/Adulterated	N/A *
December 03, 2004	Mind's Eye Juice Company	Seattle District Office	CGMP for Foods/Juice HACCP/Adulterated/Misbranded	N/A *
December 02, 2004	Colloids for Life, LLC	Denver District Office	Labeling/Promotional Claims False & Misleading/New Drug	N/A *
December 02, 2004	Purest Colloids, Inc.	New Jersey District Office	Promotional Claims/False & Misleading/Misbranded	N/A *

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