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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
07/06/2006 Gonzalez, Evangeline G., M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
07/05/2006 Driftwood Management, LLC [ARCHIVED] Florida District Office Labeling/False & Misleading Claims/New Drug N/A *
07/05/2006 Inpromar Seafood, Inc. [ARCHIVED] Florida District Office Current Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated N/A *
07/03/2006 Peco Foods Inc [ARCHIVED] New Orleans District Office Current Good Manufacturing Practice for Medicated Feed/Adulterated N/A *
07/03/2006 Pro Trainers Choice Company, Inc. [ARCHIVED] Seattle District Office Quality System Regulation/Medical Device Reporting/Adulterated N/A *
06/30/2006 Sanofi Pasteur [ARCHIVED] Office of Enforcement Current Good Manufacturing Practices N/A *
06/29/2006 Regco Corporation, Inc. [ARCHIVED] New England District Office Food Labeling/Misbranded N/A *
06/28/2006 The Power Mall [ARCHIVED] Kansas City District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
06/28/2006 Spiro, Scott A., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
06/27/2006 Winspan, Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
06/23/2006 Guilin Pharmaceutical Corporation, Limited [ARCHIVED] Center for Veterinary Medicine Current Good Manufacturing Practices/Active Pharmaceuticals Ingredient/Adulterated N/A *
06/23/2006 Harvest Time Seafood, Inc [ARCHIVED] New Orleans District Office Seafood HACCP/Adulterated N/A *
06/23/2006 Vandenberg Dairy [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
06/22/2006 International BioResources LLC [ARCHIVED] Dallas District Office Current Good Manufacturing Practices for Blood and Blood Components N/A *
06/22/2006 Vail Valley Medical Center IRB [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
06/21/2006 Sun Farm Corporation [ARCHIVED] New England District Office Labeling/Promotional Claims False & Misleading/New Drug N/A *
06/19/2006 Watson Laboratories Caribe, Inc. [ARCHIVED] San Juan District Office CGMP Regulations for Finished Pharmaceuticals/Adulterated N/A *
06/16/2006 Cristofanilli, Massimo M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
06/16/2006 Harry Flyod Livestock, Inc. New Orleans District Office Illegal Drug Residue N/A *
06/15/2006 Ranbaxy Laboratories Limited [ARCHIVED] Center for Drug Evaluation and Research Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
06/15/2006 Cell Point, LLC [ARCHIVED] Center for Drug Evaluation and Research Sponsor/Monitor/Contract Research Organization N/A *
06/15/2006 MD Anderson Cancer Center [ARCHIVED] Center for Drug Evaluation and Research Radioactive Drug Research Committee (RDRC)/Institutional Review Board (IRB) N/A *
06/14/2006 Bioesl Packing Company, Inc. [ARCHIVED] Baltimore District Office Lacks New Animal Drug Application/Adulterated N/A *
06/14/2006 Envita Natural Medical Centers of America [ARCHIVED] Center for Biologics Evaluation and Research Sponsor/Monitor/Contract Research Organization N/A *
06/13/2006 Best Choice Trading Corporation [ARCHIVED] New York District Office Seafood HACCP/Adulterated N/A *
06/12/2006 Vapotherm, Inc. [ARCHIVED] Baltimore District Office CGMP for Medical Devices/Medical Device Reporting/Adulterated N/A *
06/09/2006 Byma, Benjamin New York District Office Illegal Drug Residue N/A *
06/08/2006 Gaymar Industries, Inc. [ARCHIVED] New York District Office CGMP for Medical Devices/Lacks Premarket Approval Application/Adulterated N/A *
06/08/2006 Aksys, Ltd [ARCHIVED] Center for Devices and Radiological Health Lacks Premarket Approval Application/Adulterated/Misbranded N/A *
06/07/2006 Double O Farms [ARCHIVED] Cincinnati District Office Interstate Conveyance Sanitation/Control of Communicable Disease N/A *
06/05/2006 Bar VP Dairy San Francisco District Office Illegal Drug Residue N/A *
06/02/2006 Slade Gorton & Company, Inc. [ARCHIVED] New England District Office Current Good Manufacturing Practice Regulation for Foods/Seafood HACCP/Adulterated N/A *
06/02/2006 J.B. Timmermann Farms Limited Chicago District Office Illegal Drug Residue N/A *
06/02/2006 Tri-State Hospital Supply Corporation [ARCHIVED] Detroit District Office CGMP for Medical Device Reporting/Adulterated N/A *
06/02/2006 Esh Foods LLC [ARCHIVED] Philadelphia District Office Current Good Manufacturing Practice Regulation for Foods/Seafood HACCP/Adulterated N/A *
06/02/2006 Siegmund Strauss Inc [ARCHIVED] New York District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
06/01/2006 Dux Industries Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Device Reporting/Adulterated N/A *
06/01/2006 Electric Mobility Corporation [ARCHIVED] New Jersey District Office Quality System Regulation for Medical Devices/Adulterated N/A *
06/01/2006 Visionary Contact Lens, Inc. [ARCHIVED] Los Angeles District Office QSR for Finished Devices/Adulterated N/A *
05/31/2006 Neil Laboratories Inc. [ARCHIVED] New Jersey District Office CGMP for Finished Pharmaceuticals/Misbranded/Adulterated N/A *
05/31/2006 Masterfoods USA [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Food Additive/Misbranded N/A *
05/31/2006 Korean Farms Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated N/A *
05/30/2006 Meadowbrook Dairy Los Angeles District Office Illegal Drug Residue N/A *
05/30/2006 Restorative Health Services, Inc. [ARCHIVED] New Orleans District Office Current Good Manufacturing Requirements for Medical Devices/Adulterated N/A *
05/25/2006 Tennessee Farmers Cooperative [ARCHIVED] New Orleans District Office Medicated Feed Mill/Adulterated N/A *
05/25/2006 Theo & Cheryl Van Berkum Dairy Seattle District Office Illegal Drug Residue N/A *
05/25/2006 Galesburg Institutional Review Board [ARCHIVED] Center for Biologics Evaluation and Research Institutional Review Board (IRB) N/A *
05/24/2006 Immuno-Mycologies, Inc. [ARCHIVED] Center for Devices and Radiological Health Lack Approved Premarket Application/Adulterated/Misbranded N/A *
05/24/2006 West Feeds, Inc. [ARCHIVED] Seattle District Office CGMP Requirements For Medicated Feeds/Adulterated N/A *
05/24/2006 PepsiAmericas [ARCHIVED] Minneapolis District Office Food Labeling/Adulterated N/A *

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ICECI Warning Letters

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