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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2008 Warning Letters

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Warning Letters issued in 2008

 

* 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
06/02/2008 Dherbs.com [ARCHIVED] Los Angeles District Office New Drug/Labeling/False Promotional Statements/Misbranded N/A *
05/30/2008 Sandstone Medical Technologiess, LLC [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
05/28/2008 Corces, Arturo, M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
05/28/2008 Cardinal Health 414 LLC [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated N/A *
05/27/2008 Food For Life Baking Company, Inc. [ARCHIVED] Los Angeles District Office Food Labeling Misbranded N/A *
05/27/2008 Herbs for cancer [ARCHIVED] Los Angeles District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
05/27/2008 Plant Cures Incorporated [ARCHIVED] Los Angeles District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
05/22/2008 Lexington International, LLC [ARCHIVED] Florida District Office Medical Devices/Adulterated/Misbranded N/A *
05/22/2008 Herb Time [ARCHIVED] Florida District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
05/21/2008 USA Golden Vision, Inc. [ARCHIVED] Los Angeles District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
05/21/2008 Precision Herbs, L.L.C. [ARCHIVED] Cincinnati District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
05/21/2008 Millennium Health LLC [ARCHIVED] Philadelphia District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
05/20/2008 Coral Calcium Factor [ARCHIVED] Seattle District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
05/20/2008 Vitapurity Corporation [ARCHIVED] Seattle District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
05/20/2008 JHS Natural products [ARCHIVED] Seattle District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
05/20/2008 Best on Earth Products [ARCHIVED] San Francisco District Office Promotional Claims/False & Misleading N/A *
05/20/2008 McPhail, Richard [ARCHIVED] Atlanta District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
05/20/2008 Generation's Black Salve [ARCHIVED] San Francisco District Office New Drug/False Misleading Labeling N/A *
05/20/2008 H & L Worldwide Inc. [ARCHIVED] Los Angeles District Office Promotional Claims False & Misleading/New Drugs N/A *
05/20/2008 Hampton, Burt [ARCHIVED] Dallas District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
05/20/2008 Ageless Cure, LLC [ARCHIVED] Dallas District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
05/15/2008 Steris Corporation [ARCHIVED] Cincinnati District Office Premarket Approval/Adulterated N/A *
05/08/2008 Elge, Inc. [ARCHIVED] Dallas District Office CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated N/A *
05/07/2008 Legacy Pharmaceuticals International [ARCHIVED] San Juan District Office CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated N/A *
05/06/2008 Advanced Orthopaedics of South Florida [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
05/01/2008 Nasim, Golzar MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
04/30/2008 Medical Solutions International, Inc. [ARCHIVED] Kansas City District Office CGMP/QSR/Medical Devices/Adulterated N/A *
04/28/2008 Merck & Company, Inc. [ARCHIVED] Office of Enforcement CGMP Manufacture of Licensed Biological Vaccine Products/Bulk Drug Substances/Components N/A *
04/25/2008 Stryer Biotech [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
04/23/2008 National Biological Corporation [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated N/A *
04/22/2008 Care Rehab and Orthopaedic Products, Inc. [ARCHIVED] Baltimore District Office CGMP/QSR/Medical Devices/Adulterated N/A *
04/21/2008 Changzhou SPL Company, Ltd ( a/k/a "Kaipu") [ARCHIVED] Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredients/Adulterated N/A *
04/15/2008 L. Neil Jones Food Company dba Northwest Packing Company [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
04/15/2008 Blood Center of New Jersey [ARCHIVED] New Jersey District Office Blood Products/Adulterated N/A *
04/11/2008 Juices Enterprises Inc. [ARCHIVED] New York District Office Juice HACCP/Adulterated N/A *
04/07/2008 Asfora, Wilson T. M.D. [ARCHIVED] Center for Devices and Radiological Health Sponsor-Investigator N/A *
04/04/2008 D'Ambrosia, Robert D. M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials N/A *
04/03/2008 Hato Potrero Farm, Inc [ARCHIVED] Florida District Office Promotional Claims False & Misleading/New Drug/Misbranded N/A *
04/01/2008 Philips Medical Systems, Inc [ARCHIVED] Cincinnati District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
03/28/2008 Catalent Pharma Solutions [ARCHIVED] Office of Enforcement CGMP Deviations N/A *
03/25/2008 GlaxoSmithKline [ARCHIVED] Atlanta District Office Postmarketing Adverse Drug Experience N/A *
03/20/2008 Brar, Saroj M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
03/19/2008 Hoffman, David C. D.D.S. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
03/13/2008 Hilton Becker, MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials N/A *
03/04/2008 IMULUX, LLC [ARCHIVED] Dallas District Office New Drug/False Misleading/Labeling/Misbranded N/A *
03/04/2008 Health-science-report.com [ARCHIVED] Seattle District Office Dietary Supplement/Labeling/False & Misleading Claims/Misbranded N/A *
03/04/2008 McKinnon, Blair [ARCHIVED] Center for Drug Evaluation and Research New Drug/False Misleading/Labeling/Misbranded N/A *
03/03/2008 Aidance Skincare & Topical Solutions, LLC [ARCHIVED] New England District Office Drug Labeling/Promotional Claims/Misbranded N/A *
03/03/2008 Midland Pharmaceutical LLC [ARCHIVED] Kansas City District Office CGMP for Finished Pharmaceutical/Adulterated N/A *
02/29/2008 Philips Lifeline, Inc. [ARCHIVED] Florida District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *

 

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ICECI Warning Letters

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