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
July 16, 2004	Stonington Sea Products, Inc.	New England District Office	Seafood HACCP/Adulterated	N/A *
July 16, 2004	Aap Implantate AG	Center for Devices and Radiological Health	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	N/A *
July 15, 2004	Airway Clearing Tools	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterated	N/A *
July 14, 2004	Inceptio Medical Technologies, L.C.	Denver District Office	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	N/A *
July 14, 2004	Expanded Vision	Center for Devices and Radiological Health	Lacks Premarket Approval/Adulterated/Misbranded	N/A *
July 14, 2004	Buns Master Bakery, Inc.	Seattle District Office	Food Labeling/Adulterated/Misbranded	N/A *
July 14, 2004	Croley, Thomas L., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
July 13, 2004	Smoot, John Brannon, M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
July 13, 2004	Gentere, Inc.	Cincinnati District Office	Pharmacy Compounding/GMP/Adulterated/Drug Labeling, Registration/Misbranded	N/A *
July 13, 2004	Peters, Thomas, M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
July 13, 2004	Evermed Corporation	Los Angeles District Office	Good Manufacturing Practice for Medical Devices Regulation/Quality System/Adulterated	N/A *
July 13, 2004	Roy and Gladice Luth Farm	Chicago District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *
July 12, 2004	Central Florida Eye Institute	Center for Devices and Radiological Health	Institutional Review Board	N/A *
July 12, 2004	Illini Feeds, Inc.	Chicago District Office	Animal Proteins Prohibited in Ruminant Feed/Misbranded	N/A *
July 08, 2004	Bounty Seafood	New England District Office	Seafood HACCP/Adulterated	N/A *
July 08, 2004	Avon Seafood	Atlanta District Office	Seafood HACCP/Adulterated	N/A *
July 08, 2004	Sansone's Seafood Market, Inc.	Philadelphia District Office	Seafood HACCP/Adulterated	N/A *
July 08, 2004	BioMerieux, Inc.	Atlanta District Office	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	N/A *
July 07, 2004	Glustitch Incorporated	Center for Devices and Radiological Health	GMP Requirements for Quality System Regulation/Dental Products/Adulterated	N/A *
July 07, 2004	Cordis Corporation	Center for Devices and Radiological Health	Sponsor Obligations	N/A *

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