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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
09/09/2005 Ada Veterinary Clinic, Inc. [ARCHIVED] Dallas District Office Illegal Drug Residue /Adulterated N/A *
09/08/2005 Seattle Fish Company, Inc. [ARCHIVED] Kansas City District Office Seafood HACCP/Adulterated N/A *
09/07/2005 Parker, Norva R [ARCHIVED] Dallas District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
09/07/2005 Xtreme Design, Inc. [ARCHIVED] Minneapolis District Office Lacks New Animal Drug Application N/A *
09/07/2005 Electro Medical, Inc. [ARCHIVED] Dallas District Office Current Good Manufacturing Practice/Adulterated N/A *
09/06/2005 Endurance Products Company, Inc. [ARCHIVED] Seattle District Office Promotional Claims False & Misleading/New Drugs N/A *
09/01/2005 Sunburst Trout Company, LLC [ARCHIVED] Atlanta District Office Seafood HACCP/Adulterated N/A *
08/31/2005 Mackie International, Inc. [ARCHIVED] Los Angeles District Office False & Misleading Claims/Misbranded N/A *
08/31/2005 Providence Dairy [ARCHIVED] Denver District Office Illegal Drug Residue /Adulterated N/A *
08/31/2005 Octapharma USA, Inc. [ARCHIVED] Center for Biologics Evaluation and Research Labeling/Promotional Claims False & Misleading/Misbranded N/A *
08/30/2005 Ulrich GmbH & Co. KG [ARCHIVED] Center for Devices and Radiological Health Current Good Manufacturing Practice/adulterated/misbranded N/A *
08/30/2005 Beverly Hills Prostetics Orthotics, Inc. [ARCHIVED] Los Angeles District Office Current Good Manufacturing Practice/Adulterated N/A *
08/26/2005 Tepnel Diagnostics Ltd. [ARCHIVED] Center for Devices and Radiological Health Lacks Premarket Approval Application Adulterated N/A *
08/25/2005 Saliva Diagnostic Systems, Inc. [ARCHIVED] Center for Biologics Evaluation and Research Sponsor/Monitor/Contract Research Organization N/A *
08/25/2005 Efoora, Inc. [ARCHIVED] Center for Biologics Evaluation and Research Sponsor/Monitor/Contract Research Organization N/A *
08/25/2005 A Perfect Food Company, LLC [ARCHIVED] Florida District Office Promotional Claims/New Drug/Misbranded N/A *
08/25/2005 Bowerman, Freddie J. & Letitia [ARCHIVED] Dallas District Office Illegal Drug Residue /Adulterated N/A *
08/25/2005 Alpha Omega Manufacturing, Inc. [ARCHIVED] Dallas District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
08/25/2005 Southern Implants, LLC [ARCHIVED] Center for Devices and Radiological Health Current Good Manufacturing Practice Regulation/Adulterated N/A *
08/23/2005 Gottlieb, Michael S., M.D. [ARCHIVED] Center for Biologics Evaluation and Research Clinical Investigator N/A *
08/23/2005 Estill Medical Technologies, Inc. [ARCHIVED] Dallas District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
08/22/2005 Tyco Healthcare Group [ARCHIVED] Center for Devices and Radiological Health Current Good Manufacturing Practice Requirements for Medical Devices/Quality System Regulation N/A *
08/22/2005 Universal Nutraceuticals, Inc. [ARCHIVED] Baltimore District Office Labeling/Promotional Claims False & Misleading/New Drug N/A *
08/19/2005 Oklahoma Blood Institute [ARCHIVED] Dallas District Office Current Good Manufacturing Practices for Blood & Components/Adulterated N/A *
08/19/2005 Furst McNess Company [ARCHIVED] Cincinnati District Office Current Good Manufacturing Practice for Medicated Feeds/Adulterated N/A *
08/18/2005 Can-X Products, Inc. [ARCHIVED] San Francisco District Office Dietary Supplement Labeling Regulations/Misbranded N/A *
08/18/2005 Enzymology Research Center, Inc. [ARCHIVED] Minneapolis District Office Labeling/Promotional Claims False & Misleading/Misbranded N/A *
08/18/2005 Neukon Groves, Inc. [ARCHIVED] Florida District Office Juice HACCP N/A *
08/18/2005 UltraFoods, Inc. [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
08/18/2005 Martin-Vue Farms [ARCHIVED] Detroit District Office Illegal Tissue Residues/Adulterated N/A *
08/16/2005 Chiyoda Sushi New York, Inc. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
08/16/2005 Chiyoda Sushi New York Inc [ARCHIVED] New York District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
08/16/2005 Similasan AG [ARCHIVED] Center for Drug Evaluation and Research Cuurent Good Manufacturing Practice/Adulterated/Misbranded N/A *
08/15/2005 Lifestream Medical Corporation [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
08/11/2005 Haidylena for Advanced Medical Industries [ARCHIVED] Center for Devices and Radiological Health Current Good Manufacturing Practice Regulation/Adulterated N/A *
08/11/2005 AM2 PAT, Inc [ARCHIVED] Atlanta District Office Quality System Regulation/Adulterated N/A *
08/10/2005 Hispamer Distributors, Inc. [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
08/10/2005 G & G Dairy [ARCHIVED] Seattle District Office Illegal Drug Residue /Adulterated N/A *
08/10/2005 Boston Scientific Corporation [ARCHIVED] New England District Office Current Good Manufacturing Practice (CGMP) requirements for medical devices/adulterated N/A *
08/09/2005 Lifeway Foods, Inc. [ARCHIVED] Philadelphia District Office Seafood HACCP/Misbranded N/A *
08/08/2005 E.A. Sween Company [ARCHIVED] Minneapolis District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated N/A *
08/04/2005 I.V. Flush, LLC [ARCHIVED] Dallas District Office Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated N/A *
08/03/2005 Arrow International, Inc. [ARCHIVED] Dallas District Office Current Good Manufacturing Practice (CGMP) Adulterated/Misbranded N/A *
08/02/2005 Keeler's Medical Supply, Inc. [ARCHIVED] Seattle District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
08/02/2005 Mike's Seafood [ARCHIVED] New Orleans District Office Seafood HACCP/Adulterated N/A *
08/01/2005 Boston Scientific Corporation [ARCHIVED] New York District Office Quality System Regulation/Adulterated N/A *
08/01/2005 Huntsville Hospital Institutional Review Committee [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
08/01/2005 Marlen Martin Farm [ARCHIVED] Detroit District Office Illegal Drug Residue/Adulterated N/A *
07/29/2005 BioMerieux, Inc. [ARCHIVED] Office of Enforcement CGMP/IVR Manufacturing N/A *
07/29/2005 Halstead Springs, Inc. [ARCHIVED] New Orleans District Office CGMP/Processing & Bottling of Bottled Drinking Water Regulations/Adulterated N/A *

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