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
October 19, 2004	Computerized Radiation Scanners, Inc.	Florida District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
October 19, 2004	Lowlyn Pharmacies, Inc.	Dallas District Office	Unapproved New Animal Drug/Adulterated	N/A *
October 18, 2004	Bear Creek Country Kitchens, LLC	Denver District Office	Labeling/False & Misleading	N/A *
October 15, 2004	American Diagnostica, Inc.	New England District Office	CGMP for Medical Devices/QSR/Adulterated/Misbranded	N/A *
October 14, 2004	Dale Dental, Inc.	Dallas District Office	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	N/A *
October 14, 2004	Berkeley Premium Nutraceuticals	Cincinnati District Office	Lacks Approved New Drug Application/Labeling/False & Misleading/Misbranded	N/A *
October 13, 2004	Fischer Industries, Inc.	Chicago District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
October 13, 2004	Cut Right Seafood, Inc.	Florida District Office	Seafood HACCP/Adulterated	N/A *
October 12, 2004	Dos Amigos Distributors, Inc.	Dallas District Office	Interstate Commerce/Misbranded	N/A *
October 12, 2004	Aventis Behring, L.L.C.	Center for Biologics Evaluation and Research	Promotional Claims/False & Misleading	N/A *
October 08, 2004	Sterex International Limited	Center for Devices and Radiological Health	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	N/A *
October 08, 2004	Tecan US	Atlanta District Office	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	N/A *
October 08, 2004	Lifecore Biomedical, Inc.	Center for Devices and Radiological Health	Medical Device Reporting/Misbranded	N/A *
October 08, 2004	MCR American Phamaceuticals Inc.	Florida District Office	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 06, 2004	Carpal Kinetics, LLC	Center for Devices and Radiological Health	Premarket Approval/Misbranded	N/A *
October 06, 2004	Total Vein Solutions Inc	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterated	N/A *
October 05, 2004	3TP LLC	Center for Devices and Radiological Health	Premarket Approval/Misbranded	N/A *
October 05, 2004	Southwind Foods, LLC	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
October 05, 2004	Comercializadors Albino S.A. de C.V.	Center for Food Safety and Applied Nutrition	Seafood HACCP	N/A *
October 05, 2004	Sugih Instrumendo Abadi, Pt.	Center for Devices and Radiological Health	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	N/A *

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