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
September 14, 2004	O'Bier Seafood Inc.	Baltimore District Office	Seafood HACCP/Adulterated	N/A *
September 13, 2004	St. Simons Altama Sfd, Inc.	Atlanta District Office	Seafood HACCP	N/A *
September 10, 2004	Whitelyn Farms, Inc.	Baltimore District Office	Animal Sale for Slaughter as Food/Adulterated	N/A *
September 10, 2004	Sokol, Dawn M., M.D.	Center for Biologics Evaluation and Research	Clinical Investigator	N/A *
September 10, 2004	Mississippi Seafood Exchange, Inc.	New Orleans District Office	Seafood HACCP/Adulterated	N/A *
September 09, 2004	Tumed Surgical Instruments & Hospital Supplies GmbH	Center for Devices and Radiological Health	CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation	N/A *
September 09, 2004	Golden Link, Inc.	Chicago District Office	Good Manufacturing Practice Regulations for Foods/Seafood HACCP	N/A *
September 08, 2004	General Medical Company	Los Angeles District Office	QSR for Medical Devices/Medical Device Reporting/Misbranded/Adulterated	N/A *
September 07, 2004	Tabatchnick Fine Foods, Inc	New Jersey District Office	Food Labeling/Misbranded	N/A *
September 03, 2004	Whitesides Dairy, Inc.	Seattle District Office	Illegal Drug Residue, Animal Tissue/Adulterated/Extra Label Drug Use	N/A *
September 02, 2004	Nelson Crab, Inc.	Seattle District Office	Seafood HACCP/Adulterated	N/A *
September 02, 2004	Redfield Feed Service	Minneapolis District Office	Extra Label Drug Use/Misbranded	N/A *
September 02, 2004	Lake Country Veterinary Service, P.A.	Minneapolis District Office	Extralabel Drug Use in Animals/Adulterated	N/A *
September 02, 2004	Roche Diagnostics Corporation	Detroit District Office	Lacks Premarket Approval/Adulterated/Misbranded	N/A *
September 01, 2004	Hitchcock Feed Service	Minneapolis District Office	Extra Label Drug Use/Misbranded	N/A *
September 01, 2004	Sybaritic, Incorporated	Minneapolis District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
August 31, 2004	Terumo Cardiovascular Systems Corp.	Detroit District Office	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	N/A *
August 31, 2004	J & D Star Dairy	Los Angeles District Office	Illegal Drug Residue, Animal Tissue/Adulterated/Extra Label Drug Use	N/A *
August 31, 2004	G.T. Laboratories	Chicago District Office	Quality System Regulation/Adulterated	N/A *
August 31, 2004	Bilchik, Anton J., M.D., Ph.D.	Center for Biologics Evaluation and Research	Clinical Investigator	N/A *

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