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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2006 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
July 07, 2006 Higher Power, Inc [ARCHIVED] Seattle District Office Labeling/Dietary Supplements/False & Misleading Claims/New Drug N/A *
July 07, 2006 Roha U.S.A., LLC [ARCHIVED] Center for Food Safety and Applied Nutrition Color Additives Certification N/A *
July 06, 2006 Stachniw, Myron B., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
July 06, 2006 Gonzalez, Evangeline G., M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
July 05, 2006 Driftwood Management, LLC [ARCHIVED] Florida District Office Labeling/False & Misleading Claims/New Drug N/A *
July 05, 2006 Inpromar Seafood, Inc. [ARCHIVED] Florida District Office Current Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated N/A *
July 03, 2006 Peco Foods Inc [ARCHIVED] New Orleans District Office Current Good Manufacturing Practice for Medicated Feed/Adulterated N/A *
July 03, 2006 Pro Trainers Choice Company, Inc. [ARCHIVED] Seattle District Office Quality System Regulation/Medical Device Reporting/Adulterated N/A *
June 30, 2006 Sanofi Pasteur [ARCHIVED] Office of Enforcement Current Good Manufacturing Practices N/A *
June 29, 2006 Regco Corporation, Inc. [ARCHIVED] New England District Office Food Labeling/Misbranded N/A *
June 28, 2006 The Power Mall [ARCHIVED] Kansas City District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
June 28, 2006 Spiro, Scott A., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
June 27, 2006 Winspan, Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
June 23, 2006 Guilin Pharmaceutical Corporation, Limited [ARCHIVED] Center for Veterinary Medicine Current Good Manufacturing Practices/Active Pharmaceuticals Ingredient/Adulterated N/A *
June 23, 2006 Harvest Time Seafood, Inc [ARCHIVED] New Orleans District Office Seafood HACCP/Adulterated N/A *
June 23, 2006 Vandenberg Dairy [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
June 22, 2006 International BioResources LLC [ARCHIVED] Dallas District Office Current Good Manufacturing Practices for Blood and Blood Components N/A *
June 22, 2006 Vail Valley Medical Center IRB [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
June 21, 2006 Sun Farm Corporation [ARCHIVED] New England District Office Labeling/Promotional Claims False & Misleading/New Drug N/A *
June 19, 2006 Watson Laboratories Caribe, Inc. [ARCHIVED] San Juan District Office CGMP Regulations for Finished Pharmaceuticals/Adulterated N/A *
June 16, 2006 Cristofanilli, Massimo M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
June 16, 2006 Harry Flyod Livestock, Inc. New Orleans District Office Illegal Drug Residue N/A *
June 15, 2006 Ranbaxy Laboratories Limited [ARCHIVED] Center for Drug Evaluation and Research Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
June 15, 2006 Cell Point, LLC [ARCHIVED] Center for Drug Evaluation and Research Sponsor/Monitor/Contract Research Organization N/A *
June 15, 2006 MD Anderson Cancer Center [ARCHIVED] Center for Drug Evaluation and Research Radioactive Drug Research Committee (RDRC)/Institutional Review Board (IRB) N/A *
June 14, 2006 Bioesl Packing Company, Inc. [ARCHIVED] Baltimore District Office Lacks New Animal Drug Application/Adulterated N/A *
June 14, 2006 Envita Natural Medical Centers of America [ARCHIVED] Center for Biologics Evaluation and Research Sponsor/Monitor/Contract Research Organization N/A *
June 13, 2006 Best Choice Trading Corporation [ARCHIVED] New York District Office Seafood HACCP/Adulterated N/A *
June 12, 2006 Vapotherm, Inc. [ARCHIVED] Baltimore District Office CGMP for Medical Devices/Medical Device Reporting/Adulterated N/A *
June 09, 2006 Byma, Benjamin New York District Office Illegal Drug Residue N/A *
June 08, 2006 Gaymar Industries, Inc. [ARCHIVED] New York District Office CGMP for Medical Devices/Lacks Premarket Approval Application/Adulterated N/A *
June 08, 2006 Aksys, Ltd [ARCHIVED] Center for Devices and Radiological Health Lacks Premarket Approval Application/Adulterated/Misbranded N/A *
June 07, 2006 Double O Farms [ARCHIVED] Cincinnati District Office Interstate Conveyance Sanitation/Control of Communicable Disease N/A *
June 05, 2006 Bar VP Dairy San Francisco District Office Illegal Drug Residue N/A *
June 02, 2006 Slade Gorton & Company, Inc. [ARCHIVED] New England District Office Current Good Manufacturing Practice Regulation for Foods/Seafood HACCP/Adulterated N/A *
June 02, 2006 J.B. Timmermann Farms Limited Chicago District Office Illegal Drug Residue N/A *
June 02, 2006 Tri-State Hospital Supply Corporation [ARCHIVED] Detroit District Office CGMP for Medical Device Reporting/Adulterated N/A *
June 02, 2006 Esh Foods LLC [ARCHIVED] Philadelphia District Office Current Good Manufacturing Practice Regulation for Foods/Seafood HACCP/Adulterated N/A *
June 02, 2006 Siegmund Strauss Inc [ARCHIVED] New York District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
June 01, 2006 Dux Industries Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Device Reporting/Adulterated N/A *
June 01, 2006 Electric Mobility Corporation [ARCHIVED] New Jersey District Office Quality System Regulation for Medical Devices/Adulterated N/A *
June 01, 2006 Visionary Contact Lens, Inc. [ARCHIVED] Los Angeles District Office QSR for Finished Devices/Adulterated N/A *
May 31, 2006 Neil Laboratories Inc. [ARCHIVED] New Jersey District Office CGMP for Finished Pharmaceuticals/Misbranded/Adulterated N/A *
May 31, 2006 Masterfoods USA [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Food Additive/Misbranded N/A *
May 31, 2006 Korean Farms Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated N/A *
May 30, 2006 Meadowbrook Dairy Los Angeles District Office Illegal Drug Residue N/A *
May 30, 2006 Restorative Health Services, Inc. [ARCHIVED] New Orleans District Office Current Good Manufacturing Requirements for Medical Devices/Adulterated N/A *
May 25, 2006 Tennessee Farmers Cooperative [ARCHIVED] New Orleans District Office Medicated Feed Mill/Adulterated N/A *
May 25, 2006 Theo & Cheryl Van Berkum Dairy Seattle District Office Illegal Drug Residue N/A *
May 25, 2006 Galesburg Institutional Review Board [ARCHIVED] Center for Biologics Evaluation and Research Institutional Review Board (IRB) N/A *

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ICECI Warning Letters

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Food and Drug Administration

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