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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2006 Warning Letters

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Tobacco Retailer Warning Letters

 

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Warning Letters issued in 2006

 

* 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

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
July 11, 2006 Baugher Enterprise, Inc. Baltimore District Office Juice HACCP/Adulterated N/A *
July 11, 2006 Herbin Tonics LLC Los Angeles District Office False & Misleading Claims/New Drug/Misbranded N/A *
July 11, 2006 Actra-Rx Los Angeles District Office False & Misleading Claims/New Drug/Misbranded N/A *
July 11, 2006 Cardiac Science Corporation Minneapolis District Office CGMP for Medical Devices/Adulterated N/A *
July 10, 2006 Jeff's Gourmet Pies, Inc. Florida District Office Food Labeling/Misbranded N/A *
July 10, 2006 Choraphor.com Seattle District Office Promotional Claims False & Misleading/New Drug/Misbranded N/A *
July 10, 2006 Parnell Pharmaceuticals, Inc. Center for Devices and Radiological Health Lacks Premarket Approval Application/Misbranded N/A *
July 10, 2006 Oklahoma Blood Institute Institutional Review Board Center for Biologics Evaluation and Research Institutional Review Board (IRB) N/A *
July 10, 2006 International Biophysics Corporation Dallas District Office CGMP for Medical Devices/Medical Device Reporting/Adulterated N/A *
July 10, 2006 Hohmann, Elizabeth L., M.D. Center for Biologics Evaluation and Research Clinical Investigator N/A *
July 10, 2006 Care Products Inc Dallas District Office CGMP for Medical Devices/Medical Device Reporting/Adulterated N/A *
July 07, 2006 Roha U.S.A., LLC Center for Food Safety and Applied Nutrition Color Additives Certification N/A *
July 07, 2006 Higher Power, Inc Seattle District Office Labeling/Dietary Supplements/False & Misleading Claims/New Drug N/A *
July 06, 2006 Stachniw, Myron B., M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
July 06, 2006 Gonzalez, Evangeline G., M.D. Center for Drug Evaluation and Research Clinical Investigator N/A *
July 05, 2006 Driftwood Management, LLC Florida District Office Labeling/False & Misleading Claims/New Drug N/A *
July 05, 2006 Inpromar Seafood, Inc. Florida District Office Current Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated N/A *
July 03, 2006 Pro Trainers Choice Company, Inc. Seattle District Office Quality System Regulation/Medical Device Reporting/Adulterated N/A *
July 03, 2006 Peco Foods Inc New Orleans District Office Current Good Manufacturing Practice for Medicated Feed/Adulterated N/A *
June 30, 2006 Sanofi Pasteur Office of Enforcement Current Good Manufacturing Practices N/A *



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ICECI Warning Letters

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Food and Drug Administration

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Rockville, MD 20857
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