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2005 Warning Letters

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Tobacco Retailer Warning Letters

 

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* 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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
02/16/2005 Neilsen Seafood [ARCHIVED] New Orleans District Office Seafood HACCP/Adulterated N/A *
02/16/2005 Icon Interventional Systems, Inc. [ARCHIVED] Cincinnati District Office Import for Export/Lacks Premarket Approval N/A *
02/15/2005 Tennant, Jerald L., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
02/15/2005 Medsep Corporation [ARCHIVED] Los Angeles District Office GMP for the Quality system Regulation/CGMP for Finished Pharmaceuticals/Adulterated N/A *
02/15/2005 Subcon Manufacturing Corporation [ARCHIVED] Chicago District Office QSR/Medical Devices/Adulterated N/A *
02/15/2005 Two Rivers LLC [ARCHIVED] New Orleans District Office CGMP Requirements of the Quality System Regulations/Adulterated N/A *
02/14/2005 Seafood Connection, Inc. [ARCHIVED] San Francisco District Office Seafood HACCP/Adulterated N/A *
02/11/2005 Jose Luis Perez Padin Farm [ARCHIVED] San Juan District Office Animals for Sale for Slaughter as Food/Adulterated N/A *
02/11/2005 Oro Blanco, Inc. [ARCHIVED] Denver District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
02/10/2005 Spectrum Laboratories, Inc. [ARCHIVED] Dallas District Office CGMP Requirements of the Quality System Regulations/Adulterated/Misbranded N/A *
02/10/2005 Japan Food Corporation [ARCHIVED] San Francisco District Office Seafood HACCP/Adulterated N/A *
02/09/2005 Cohen, Richard M.D. [ARCHIVED] Atlanta District Office Labeling / New Drug Application N/A *
02/09/2005 South Bay OBGYN [ARCHIVED] Buffalo District Office Mammography Quality Standards N/A *
02/08/2005 Ysselstein Dairy, Inc. [ARCHIVED] Kansas City District Office Illegal Drug Residue/Adulterated N/A *
02/08/2005 R-Garden, Inc. [ARCHIVED] Seattle District Office Labeling/False & Misleading Claims/Misbranded N/A *
02/07/2005 W.W. Cattle Company [ARCHIVED] Dallas District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated N/A *
02/07/2005 Electronic Data Systems [ARCHIVED] Baltimore District Office Current Good Manufacturing Practice Requirements for Medical Devices/Quality System Regulation N/A *
02/04/2005 Merazon Health Products, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/Misbranded N/A *
02/04/2005 Allergy Laboratories of Ohio, Inc. [ARCHIVED] Office of Enforcement Current Good Manufacturing Practice N/A *
02/04/2005 The Sporicidin Company [ARCHIVED] Baltimore District Office Current Good Manufacturing Practice for Medical Devices N/A *
02/03/2005 The Bryan Company, Inc. [ARCHIVED] Los Angeles District Office CGMP Requirements of the Quality System Regulations/Adulterated/Misbranded N/A *
02/02/2005 Eastland Seafood, Inc. [ARCHIVED] New York District Office Seafood HACCP/Adulterated N/A *
02/01/2005 Sovereign Seafoods, Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated N/A *
02/01/2005 Katros Groves/Citrus Direct [ARCHIVED] Florida District Office Current Good Manufacturing Practices Regulation for Foods/Juice HACCP/Adulterated N/A *
02/01/2005 Medelle Corporation [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
02/01/2005 Diopsys, Inc. [ARCHIVED] New Jersey District Office Quality System Regulation for Medical Devices/Adulterated N/A *
02/01/2005 Mayne Pharma (USA) Inc. [ARCHIVED] New Jersey District Office Postmarketing Adverse Drug Experience Reporting Requirements N/A *
02/01/2005 Advanced Bionics Corporation [ARCHIVED] Los Angeles District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
01/31/2005 Wax Orchard's Inc. [ARCHIVED] Seattle District Office Juice HACCP/Adulterated N/A *
01/28/2005 Gene Logic, Inc. [ARCHIVED] Center for Drug Evaluation and Research Good Laboratory Practice (GLP) N/A *
01/27/2005 Marcum, John W., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
01/27/2005 Newhouse Dairy Processing LLC [ARCHIVED] Kansas City District Office Juice HACCP N/A *
01/25/2005 Nutraceutical Labs, Inc. [ARCHIVED] Los Angeles District Office Labeling/Dietary Supplements/CGMP for Finished Pharmaceuticals/Adulterated N/A *
01/21/2005 E-Lyte Incorporated [ARCHIVED] New Jersey District Office New Drug/Labeling/False & Misleading Claims N/A *
01/20/2005 Basic Research, LLC [ARCHIVED] Denver District Office Labeling/Promotional Claims False & Misleading/New Drug N/A *
01/19/2005 GE Healthcare Technologies [ARCHIVED] Minneapolis District Office Performance Standards for Diagnostic X-ray Equipment N/A *
01/19/2005 Crittenton Hospital Medical Center [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
01/14/2005 Archer Daniels Midland Company [ARCHIVED] Kansas City District Office CGMP/Medicated Feeds/Adulterated N/A *
01/14/2005 Basic Research, LLC [ARCHIVED] Denver District Office Labeling/Promotional Claims False & Misleading/New Drug N/A *
01/13/2005 Warehouse Food Group, LLC [ARCHIVED] New Orleans District Office Seafood HACCP/Adulterated N/A *
01/12/2005 Brown Cattle Company [ARCHIVED] Dallas District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated N/A *
01/12/2005 Greenland, Inc. [ARCHIVED] Seattle District Office Labeling/False & Misleading Claims/Misbranded N/A *
01/10/2005 Faaborg Rehab Technic ApS [ARCHIVED] Center for Devices and Radiological Health Current Good Manufacturing Practice/Adulterated N/A *
01/10/2005 Cincinnati Sub-Zero Products [ARCHIVED] Cincinnati District Office Quality System Regulation/Adulterated/Misbranded N/A *
01/10/2005 Arjo Med. AB Ltd. [ARCHIVED] Center for Devices and Radiological Health Current Good Manufacturing Practice/Adulterated N/A *
01/07/2005 Peter Schiff Enterprises [ARCHIVED] New Orleans District Office Current Good Manufacturing Practice/Adulterated N/A *
01/07/2005 Essential Pharmacy Compounding [ARCHIVED] Kansas City District Office Pharmacy Compounding/Adulterated N/A *
01/07/2005 Quantum Inc [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/New Drug/False & Misleading Claims/Misbranded N/A *
01/07/2005 Chi Machine International [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/New Drug/False & Misleading Claims/Misbranded N/A *
01/07/2005 Thinking Systems Corp. [ARCHIVED] Florida District Office Quality System Regulation/Adulterated/Misbranded N/A *

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