2005 Warning Letters

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Warning Letters issued in 2005

 

* 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 February 02, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
February 17, 2005	Quality Liquid Feeds	Cincinnati District Office	Current Good Manufacturing Practice for Medicated Feeds/Adulterated	N/A *
February 17, 2005	Everglades Fish Company L.L.C.	Florida District Office	Seafood HACCP/Adulterated	N/A *
February 16, 2005	Ka'u Ice and Fishing Supply	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
February 16, 2005	Neilsen Seafood	New Orleans District Office	Seafood HACCP/Adulterated	N/A *
February 16, 2005	Icon Interventional Systems, Inc.	Cincinnati District Office	Import for Export/Lacks Premarket Approval	N/A *
February 15, 2005	Medsep Corporation	Los Angeles District Office	GMP for the Quality system Regulation/CGMP for Finished Pharmaceuticals/Adulterated	N/A *
February 15, 2005	Subcon Manufacturing Corporation	Chicago District Office	QSR/Medical Devices/Adulterated	N/A *
February 15, 2005	Two Rivers LLC	New Orleans District Office	CGMP Requirements of the Quality System Regulations/Adulterated	N/A *
February 15, 2005	Tennant, Jerald L., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
February 14, 2005	Seafood Connection, Inc.	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
February 11, 2005	Oro Blanco, Inc.	Denver District Office	Current Good Manufacturing Practice Regulation/Adulterated	N/A *
February 11, 2005	Jose Luis Perez Padin Farm	San Juan District Office	Animals for Sale for Slaughter as Food/Adulterated	N/A *
February 10, 2005	Spectrum Laboratories, Inc.	Dallas District Office	CGMP Requirements of the Quality System Regulations/Adulterated/Misbranded	N/A *
February 10, 2005	Japan Food Corporation	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
February 09, 2005	Cohen, Richard M.D.	Atlanta District Office	Labeling / New Drug Application	N/A *
February 09, 2005	South Bay OBGYN	Buffalo District Office	Mammography Quality Standards	N/A *
February 08, 2005	R-Garden, Inc.	Seattle District Office	Labeling/False & Misleading Claims/Misbranded	N/A *
February 08, 2005	Ysselstein Dairy, Inc.	Kansas City District Office	Illegal Drug Residue/Adulterated	N/A *
February 07, 2005	W.W. Cattle Company	Dallas District Office	Animal Proteins Prohibited in Ruminant Feed/Adulterated	N/A *
February 07, 2005	Electronic Data Systems	Baltimore District Office	Current Good Manufacturing Practice Requirements for Medical Devices/Quality System Regulation	N/A *
February 04, 2005	Merazon Health Products, Inc.	Center for Food Safety and Applied Nutrition	Labeling/Promotional Claims False & Misleading/Misbranded	N/A *
February 04, 2005	Allergy Laboratories of Ohio, Inc.	Office of Enforcement	Current Good Manufacturing Practice	N/A *
February 04, 2005	The Sporicidin Company	Baltimore District Office	Current Good Manufacturing Practice for Medical Devices	N/A *
February 03, 2005	The Bryan Company, Inc.	Los Angeles District Office	CGMP Requirements of the Quality System Regulations/Adulterated/Misbranded	N/A *
February 02, 2005	Eastland Seafood, Inc.	New York District Office	Seafood HACCP/Adulterated	N/A *
February 01, 2005	Katros Groves/Citrus Direct	Florida District Office	Current Good Manufacturing Practices Regulation for Foods/Juice HACCP/Adulterated	N/A *
February 01, 2005	Advanced Bionics Corporation	Los Angeles District Office	Current Good Manufacturing Practice Regulation/Adulterated	N/A *
February 01, 2005	Sovereign Seafoods, Inc.	Los Angeles District Office	Seafood HACCP/Adulterated	N/A *
February 01, 2005	Medelle Corporation	Center for Devices and Radiological Health	Sponsor Obligations	N/A *
February 01, 2005	Mayne Pharma (USA) Inc.	New Jersey District Office	Postmarketing Adverse Drug Experience Reporting Requirements	N/A *
February 01, 2005	Diopsys, Inc.	New Jersey District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
January 31, 2005	Wax Orchard's Inc.	Seattle District Office	Juice HACCP/Adulterated	N/A *
January 28, 2005	Gene Logic, Inc.	Center for Drug Evaluation and Research	GLP for non-clincal laboratory studies	N/A *
January 27, 2005	Marcum, John W., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
January 27, 2005	Newhouse Dairy Processing LLC	Kansas City District Office	Juice HACCP	N/A *
January 25, 2005	Nutraceutical Labs, Inc.	Los Angeles District Office	Labeling/Dietary Supplements/CGMP for Finished Pharmaceuticals/Adulterated	N/A *
January 21, 2005	E-Lyte Incorporated	New Jersey District Office	New Drug/Labeling/False & Misleading Claims	N/A *
January 20, 2005	Basic Research, LLC	Denver District Office	Labeling/Promotional Claims False & Misleading/New Drug	N/A *
January 19, 2005	GE Healthcare Technologies	Minneapolis District Office	Performance Standards for Diagnostic X-ray Equipment	N/A *
January 19, 2005	Crittenton Hospital Medical Center	Center for Devices and Radiological Health	Institutional Review Board (IRB)	N/A *
January 14, 2005	Basic Research, LLC	Denver District Office	Labeling/Promotional Claims False & Misleading/New Drug	N/A *
January 14, 2005	Archer Daniels Midland Company	Kansas City District Office	CGMP/Medicated Feeds/Adulterated	N/A *
January 13, 2005	Warehouse Food Group, LLC	New Orleans District Office	Seafood HACCP/Adulterated	N/A *
January 12, 2005	Greenland, Inc.	Seattle District Office	Labeling/False & Misleading Claims/Misbranded	N/A *
January 12, 2005	Brown Cattle Company	Dallas District Office	Animal Proteins Prohibited in Ruminant Feed/Adulterated	N/A *
January 10, 2005	Arjo Med. AB Ltd.	Center for Devices and Radiological Health	Current Good Manufacturing Practice/Adulterated	N/A *
January 10, 2005	Cincinnati Sub-Zero Products	Cincinnati District Office	Quality System Regulation/Adulterated/Misbranded	N/A *
January 10, 2005	Faaborg Rehab Technic ApS	Center for Devices and Radiological Health	Current Good Manufacturing Practice/Adulterated	N/A *
January 07, 2005	Thinking Systems Corp.	Florida District Office	Quality System Regulation/Adulterated/Misbranded	N/A *
January 07, 2005	Chi Machine International	Center for Food Safety and Applied Nutrition	Labeling/New Drug/False & Misleading Claims/Misbranded	N/A *

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