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



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ICECI Warning Letters

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Food and Drug Administration

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