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2004 Warning Letters

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Tobacco Retailer 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

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



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ICECI Warning Letters

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