Inspections, Compliance, Enforcement, and Criminal Investigations

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.

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
June 18, 2004	Southeast Tissue Alliance, Inc.	Florida District Office	Human Tissue Intended for Transplantation	N/A *
June 18, 2004	Unifish Canning S.A.	Center for Food Safety and Applied Nutrition	Seafood HACCP/Adulterated	N/A *
June 17, 2004	Massachusetts Port Authority	New England District Office	Interstate Conveyance Sanitation Regulations	N/A *
June 17, 2004	Mastex Industries, LLC	Baltimore District Office	Quality System Regulation/Medical Devices/Adulterated	N/A *
June 17, 2004	Euro Foods USA, Inc.	New York District Office	Seafood HACCP/Adulterated	N/A *
June 17, 2004	Bayer Corporation	Detroit District Office	Quality System Regulation/Adulterated	N/A *
June 16, 2004	Downey Regional Medical Center IRC	Center for Devices and Radiological Health	Institutional Review Board	N/A *
June 16, 2004	Bailey's Basin Seafood, Inc.	New Orleans District Office	Seafood HACCP/Adulterated	N/A *
June 15, 2004	Pharma Fab	Dallas District Office	GMP for Finished Pharmaceuticals/Adulterated	N/A *
June 15, 2004	Perfect Tans and Spa	New Orleans District Office	Performance Standards, Light-Emitting Products	N/A *
June 15, 2004	Barclay Seafoods & Meat Corporation	Seattle District Office	Seafood HACCP	N/A *
June 15, 2004	Walgreen Company	Chicago District Office	Insanitary Conditions/Adulterated/Animal Protein Prohibited in Ruminant Feed Not Labeled	N/A *
June 15, 2004	Steris Corporation	Chicago District Office	Quality System Regulation/Adulterated	N/A *
June 15, 2004	Jake Slegers Jr. Dairy	San Francisco District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *
June 15, 2004	Massachusetts Institute of Technology	Center for Devices and Radiological Health	Good Laboratory Practices	N/A *
June 15, 2004	Specialty Brands, Inc.	Dallas District Office	Animal Proteins Prohibited in Ruminant Feed	N/A *
June 14, 2004	Lumenis, Inc.	Denver District Office	GMP Requirements for the Quality System Regulation/Adulterated	N/A *
June 14, 2004	Engelhard, Peter A., D.O.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
June 14, 2004	Apptec Laboratory Services, Inc.	Minneapolis District Office	Human Tissue Intended for Transplantation	N/A *
June 14, 2004	Stewart's Dairy	New York District Office	Illegal Drug Residue in Edible Tissue/Extralabel Drug Use/Adulterated	N/A *
June 10, 2004	Chapman Ranch	Dallas District Office	Animal Proteins Prohibited in Ruminant Feed/Adulterated	N/A *
June 10, 2004	B & G Seed Company	Atlanta District Office	Animal Proteins Prohibited in Ruminant Feed/Misbranded	N/A *
June 10, 2004	Reynolds, John C.	New England District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *
June 08, 2004	International Brachytherapy Inc	Atlanta District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
June 07, 2004	Peoples Pharmacy, Inc.	Dallas District Office	New Drug/Misbranded	N/A *
June 07, 2004	Drugs Are Us, Inc.	New Jersey District Office	New Drug/Misbranded	N/A *
June 07, 2004	Axium Healthcare Pharmacy	Florida District Office	New Drug/Misbranded	N/A *
June 07, 2004	Spectrum Chemicals & Laboratory Products	New Jersey District Office	New Drug/Misbranded	N/A *
June 04, 2004	Million Air Monterey	San Francisco District Office	Interstate Conveyance Sanitation Regulations	N/A *
June 04, 2004	Devine Farms, LLC	New York District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *
June 04, 2004	Biotronik, Inc.	Center for Devices and Radiological Health	Sponsor Obligations	N/A *
June 03, 2004	JB5, Inc.	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
June 03, 2004	Keller Medical Specialties Products, Inc.	Chicago District Office	QSR/Medical Device Reporting/Adulterated/Device Master Record	N/A *
June 03, 2004	Asahi Medical Company, Ltd.	Center for Devices and Radiological Health	Good Manufacturing Practice for Medical Devices Regulation/Quality System/Adulterated	N/A *
June 03, 2004	Fir Crest Hauling	Seattle District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *
June 03, 2004	Diamedix Corporation	Florida District Office	Quality System Regulation/Adulterated	N/A *
June 02, 2004	Lotte International Trading, Inc.	Seattle District Office	Food Labeling/Adulterated/Misbranded	N/A *
June 01, 2004	Cheatham, John P., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
June 01, 2004	Surgilight, Inc.	Center for Devices and Radiological Health	Sponsor Obligations	N/A *
June 01, 2004	Belmont, Sandra	Center for Devices and Radiological Health	Clinical Investigator	N/A *
June 01, 2004	Pacific Seafood Group	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
June 01, 2004	Belmont, Sandra, M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
June 01, 2004	Refrescos Yaguez, Inc.	San Juan District Office	Food Labeling/Adulterated/Misbranded	N/A *
May 27, 2004	OMRIX biopharmaceuticals, Ltd.	Center for Biologics Evaluation and Research	Promotional Claims/Misbranded	N/A *
May 27, 2004	Siegel, Robert M., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
May 27, 2004	Stanislaus Surgical Hospital IRB	Center for Devices and Radiological Health	Institutional Review Board	N/A *
May 27, 2004	James Styron Fish Company	Atlanta District Office	Seafood HACCP/Adulterated	N/A *
May 27, 2004	OMRIX biopharmaceuticals, Ltd.	Center for Biologics Evaluation and Research	Promotional Claims/Misbranded	N/A *
May 26, 2004	Vintage Pharmaceuticals, Inc.	Atlanta District Office	Postmarketing Adverse Drug Experience	N/A *
May 26, 2004	Allen & Dale Van Nurden Farm	Minneapolis District Office	Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated	N/A *

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2004 Warning Letters

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