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U.S. Department of Health and Human Services

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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
06/17/2005 Vitality Products Co., Inc. [ARCHIVED] Seattle District Office Dietary Supplements N/A *
06/16/2005 Arrow International, Inc. [ARCHIVED] Philadelphia District Office CGMP/Adulterated N/A *
06/14/2005 Mercy Medical Center [ARCHIVED] Kansas City District Office Current Good Manufacturing Practices for Blood and Blood Components N/A *
06/14/2005 American Thermal Instrument Inc. [ARCHIVED] Cincinnati District Office Quality System Reguation/Adulterated N/A *
06/13/2005 Coutts, Richard M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
06/13/2005 Asociation de Productores de Leche Camuy-Quebradillas [ARCHIVED] San Juan District Office Animal Drugs/Misbranded N/A *
06/10/2005 Puronyx, Inc. [ARCHIVED] Center for Devices and Radiological Health Lacks Premarket Approval/Adulterated N/A *
06/10/2005 Sylvester's Crawfish Processor [ARCHIVED] New Orleans District Office Seafood HACCP N/A *
06/10/2005 Jones, Alison M [ARCHIVED] Center for Biologics Evaluation and Research Clinical Investigator N/A *
06/09/2005 Medtronic Emergency Response System [ARCHIVED] Seattle District Office CGMP Requirements for Medical Devices/Adulterated N/A *
06/09/2005 The Master's Miracle, Inc. [ARCHIVED] Minneapolis District Office Promotional Claims/False & Misleading N/A *
06/09/2005 Anamax Corporation [ARCHIVED] Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed N/A *
06/07/2005 Bishop, Clark M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
06/07/2005 Millennium Dental Technologies Inc. [ARCHIVED] Los Angeles District Office Quality System Reguation/Adulterated N/A *
06/06/2005 Hostoffer, Robert W. DO [ARCHIVED] Center for Biologics Evaluation and Research Clinical Investigator N/A *
06/06/2005 Ridgecrest Dairy, LLC [ARCHIVED] New York District Office Illegal Drug Residue /Adulterated N/A *
06/03/2005 Groomer's Seafood of San Antonio [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated/Misbranded N/A *
06/03/2005 Arrow International, Inc. [ARCHIVED] New Jersey District Office Quality System Reguation/Adulterated N/A *
06/02/2005 Immunity Today, LLC [ARCHIVED] Center for Biologics Evaluation and Research Promotional Claims/False & Misleading N/A *
06/02/2005 Ovation Pharmaceuticals, Inc. [ARCHIVED] Center for Biologics Evaluation and Research Promotional Claims/False & Misleading/Misbranded N/A *
06/01/2005 Chan Ta Seafood [ARCHIVED] New Orleans District Office Seafood HACCP/Adulterated N/A *
05/31/2005 Bioteque America, Inc. [ARCHIVED] Philadelphia District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
05/27/2005 Lydall, Inc. [ARCHIVED] Atlanta District Office CGMP/Adulterated N/A *
05/26/2005 Constantine, Neil T Ph.D [ARCHIVED] Center for Biologics Evaluation and Research Clinical Investigator N/A *
05/26/2005 C & M Oxyfill, LLC [ARCHIVED] New Orleans District Office Current Good Manufacturing Practice for Finished Pharmaceuticals/Misbranded/Adulterated N/A *
05/26/2005 P.&O. Cold Logistics [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated N/A *
05/25/2005 Biolmagene, Inc. [ARCHIVED] Center for Devices and Radiological Health Lacks Approved Premarket Application/Adulterated N/A *
05/25/2005 Apollo Export Warehouse, Inc. [ARCHIVED] Florida District Office Seafood HACCP N/A *
05/24/2005 Paul Meserve Distributor [ARCHIVED] New England District Office Food Labeling/Misbranded N/A *
05/24/2005 Pascal Company, Inc. [ARCHIVED] Seattle District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
05/24/2005 Seafarers Inc. [ARCHIVED] Florida District Office Seafood HACCP N/A *
05/23/2005 Telex Communications, Inc. [ARCHIVED] Kansas City District Office Quality System Regulation/Medical Device Reporting Regulation/Misbranded/Adulerated N/A *
05/19/2005 Great & Best Co., Inc. [ARCHIVED] New Orleans District Office CGMP Manufacturing, Packing, or Holding Human Food/Adulterated N/A *
05/19/2005 Spectronics Corporation [ARCHIVED] New York District Office Quality System Regulation for Medical Devices/Adulterated N/A *
05/18/2005 Nucura Pharmaceuticals, Inc. [ARCHIVED] Los Angeles District Office Labeling/False & Misleading Claims/New Drug/Misbranded N/A *
05/18/2005 Boston Scientific Corporation [ARCHIVED] New England District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
05/17/2005 Pro*Act Specialties [ARCHIVED] Florida District Office Seafood HACCP N/A *
05/17/2005 Aunt Lizzie's Cheese Straws, Inc [ARCHIVED] New Orleans District Office Food Labeling/Misbranded N/A *
05/17/2005 Netuno USA, Inc. [ARCHIVED] Florida District Office Seafood HACCP N/A *
05/16/2005 Koppes, Thomas P [ARCHIVED] Center for Biologics Evaluation and Research Clinical Investigator N/A *
05/16/2005 Cohen, Daniel, M.D. [ARCHIVED] Center for Biologics Evaluation and Research Clinical Investigator N/A *
05/13/2005 De-Rene Dairy [ARCHIVED] Denver District Office Illegal Drug Residue /Adulterated N/A *
05/13/2005 UAS Laboratories [ARCHIVED] Minneapolis District Office Labeling/False & Misleading Claims/Misbranded N/A *
05/12/2005 J D Heiskell & Co [ARCHIVED] Los Angeles District Office CGMP/Adulterated N/A *
05/12/2005 C & E GP Specialists [ARCHIVED] Los Angeles District Office Quality System Regulations (QSR) for finished devices/adulterated N/A *
05/10/2005 Idyl Wild Farms Inc. [ARCHIVED] Cincinnati District Office Illegal Drug Residue /Adulterated N/A *
05/09/2005 Electrologic of America, Inc. [ARCHIVED] Cincinnati District Office Quality System Regulation/Adulterated N/A *
05/09/2005 Heritage Dairy [ARCHIVED] Denver District Office Illegal Drug Residue /Adulterated N/A *
05/06/2005 Philips Medizin Systeme Gmbh [ARCHIVED] Center for Devices and Radiological Health CGMP/Adulterated N/A *
05/04/2005 Eastern Treats Inc. [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *

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