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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
September 13, 2005 CEPH International Corporation [ARCHIVED] San Juan District Office CGMP/Adulterated N/A *
September 09, 2005 Ada Veterinary Clinic, Inc. [ARCHIVED] Dallas District Office Illegal Drug Residue /Adulterated N/A *
September 08, 2005 Seattle Fish Company, Inc. [ARCHIVED] Kansas City District Office Seafood HACCP/Adulterated N/A *
September 07, 2005 Parker, Norva R [ARCHIVED] Dallas District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
September 07, 2005 Xtreme Design, Inc. [ARCHIVED] Minneapolis District Office Lacks New Animal Drug Application N/A *
September 07, 2005 Electro Medical, Inc. [ARCHIVED] Dallas District Office Current Good Manufacturing Practice/Adulterated N/A *
September 06, 2005 Endurance Products Company, Inc. [ARCHIVED] Seattle District Office Promotional Claims False & Misleading/New Drugs N/A *
September 01, 2005 Sunburst Trout Company, LLC [ARCHIVED] Atlanta District Office Seafood HACCP/Adulterated N/A *
August 31, 2005 Mackie International, Inc. [ARCHIVED] Los Angeles District Office False & Misleading Claims/Misbranded N/A *
August 31, 2005 Providence Dairy [ARCHIVED] Denver District Office Illegal Drug Residue /Adulterated N/A *
August 31, 2005 Octapharma USA, Inc. [ARCHIVED] Center for Biologics Evaluation and Research Labeling/Promotional Claims False & Misleading/Misbranded N/A *
August 30, 2005 Ulrich GmbH & Co. KG [ARCHIVED] Center for Devices and Radiological Health Current Good Manufacturing Practice/adulterated/misbranded N/A *
August 30, 2005 Beverly Hills Prostetics Orthotics, Inc. [ARCHIVED] Los Angeles District Office Current Good Manufacturing Practice/Adulterated N/A *
August 26, 2005 Tepnel Diagnostics Ltd. [ARCHIVED] Center for Devices and Radiological Health Lacks Premarket Approval Application Adulterated N/A *
August 25, 2005 Saliva Diagnostic Systems, Inc. [ARCHIVED] Center for Biologics Evaluation and Research Sponsor/Monitor/Contract Research Organization N/A *
August 25, 2005 Efoora, Inc. [ARCHIVED] Center for Biologics Evaluation and Research Sponsor/Monitor/Contract Research Organization N/A *
August 25, 2005 A Perfect Food Company, LLC [ARCHIVED] Florida District Office Promotional Claims/New Drug/Misbranded N/A *
August 25, 2005 Bowerman, Freddie J. & Letitia [ARCHIVED] Dallas District Office Illegal Drug Residue /Adulterated N/A *
August 25, 2005 Alpha Omega Manufacturing, Inc. [ARCHIVED] Dallas District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
August 25, 2005 Southern Implants, LLC [ARCHIVED] Center for Devices and Radiological Health Current Good Manufacturing Practice Regulation/Adulterated N/A *
August 23, 2005 Gottlieb, Michael S., M.D. [ARCHIVED] Center for Biologics Evaluation and Research Clinical Investigator N/A *
August 23, 2005 Estill Medical Technologies, Inc. [ARCHIVED] Dallas District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
August 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 *
August 22, 2005 Universal Nutraceuticals, Inc. [ARCHIVED] Baltimore District Office Labeling/Promotional Claims False & Misleading/New Drug N/A *
August 19, 2005 Oklahoma Blood Institute [ARCHIVED] Dallas District Office Current Good Manufacturing Practices for Blood & Components/Adulterated N/A *
August 19, 2005 Furst McNess Company [ARCHIVED] Cincinnati District Office Current Good Manufacturing Practice for Medicated Feeds/Adulterated N/A *
August 18, 2005 Can-X Products, Inc. [ARCHIVED] San Francisco District Office Dietary Supplement Labeling Regulations/Misbranded N/A *
August 18, 2005 Enzymology Research Center, Inc. [ARCHIVED] Minneapolis District Office Labeling/Promotional Claims False & Misleading/Misbranded N/A *
August 18, 2005 Neukon Groves, Inc. [ARCHIVED] Florida District Office Juice HACCP N/A *
August 18, 2005 UltraFoods, Inc. [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
August 18, 2005 Martin-Vue Farms [ARCHIVED] Detroit District Office Illegal Tissue Residues/Adulterated N/A *
August 16, 2005 Chiyoda Sushi New York, Inc. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
August 16, 2005 Chiyoda Sushi New York Inc [ARCHIVED] New York District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
August 16, 2005 Similasan AG [ARCHIVED] Center for Drug Evaluation and Research Cuurent Good Manufacturing Practice/Adulterated/Misbranded N/A *
August 15, 2005 Lifestream Medical Corporation [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
August 11, 2005 Haidylena for Advanced Medical Industries [ARCHIVED] Center for Devices and Radiological Health Current Good Manufacturing Practice Regulation/Adulterated N/A *
August 11, 2005 AM2 PAT, Inc [ARCHIVED] Atlanta District Office Quality System Regulation/Adulterated N/A *
August 10, 2005 Hispamer Distributors, Inc. [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
August 10, 2005 G & G Dairy [ARCHIVED] Seattle District Office Illegal Drug Residue /Adulterated N/A *
August 10, 2005 Boston Scientific Corporation [ARCHIVED] New England District Office Current Good Manufacturing Practice (CGMP) requirements for medical devices/adulterated N/A *
August 09, 2005 Lifeway Foods, Inc. [ARCHIVED] Philadelphia District Office Seafood HACCP/Misbranded N/A *
August 08, 2005 E.A. Sween Company [ARCHIVED] Minneapolis District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated N/A *
August 04, 2005 I.V. Flush, LLC [ARCHIVED] Dallas District Office Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated N/A *
August 03, 2005 Arrow International, Inc. [ARCHIVED] Dallas District Office Current Good Manufacturing Practice (CGMP) Adulterated/Misbranded N/A *
August 02, 2005 Keeler's Medical Supply, Inc. [ARCHIVED] Seattle District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
August 02, 2005 Mike's Seafood [ARCHIVED] New Orleans District Office Seafood HACCP/Adulterated N/A *
August 01, 2005 Boston Scientific Corporation [ARCHIVED] New York District Office Quality System Regulation/Adulterated N/A *
August 01, 2005 Huntsville Hospital Institutional Review Committee [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
August 01, 2005 Marlen Martin Farm [ARCHIVED] Detroit District Office Illegal Drug Residue/Adulterated N/A *
July 29, 2005 BioMerieux, Inc. [ARCHIVED] Office of Enforcement CGMP/IVR Manufacturing N/A *

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ICECI Warning Letters

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