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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
May 29, 2008 Road to Healing [ARCHIVED] New Orleans District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
May 28, 2008 Corces, Arturo, M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
May 28, 2008 Alliance Dairies [ARCHIVED] Florida District Office Illegal Drug Residue N/A *
May 28, 2008 Cardinal Health 414 LLC [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated N/A *
May 28, 2008 Triple C Cattle Company LLC [ARCHIVED] Kansas City District Office Illegal Drug Residue N/A *
May 28, 2008 Glick, Jonathan J. [ARCHIVED] Philadelphia District Office Illegal Drug Residue N/A *
May 27, 2008 Rossmax International Ltd [ARCHIVED] Center for Devices and Radiological Health CGMP Regulation/Violations N/A *
May 27, 2008 Food For Life Baking Company, Inc. [ARCHIVED] Los Angeles District Office Food Labeling Misbranded N/A *
May 27, 2008 Herbs for cancer [ARCHIVED] Los Angeles District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
May 27, 2008 Plant Cures Incorporated [ARCHIVED] Los Angeles District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
May 27, 2008 Safer Sleep, LLC [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
May 27, 2008 Golub Corporation [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
May 23, 2008 Herbal Remission [ARCHIVED] Seattle District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
May 22, 2008 Lexington International, LLC [ARCHIVED] Florida District Office Medical Devices/Adulterated/Misbranded N/A *
May 22, 2008 Herb Time [ARCHIVED] Florida District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
May 21, 2008 USA Golden Vision, Inc. [ARCHIVED] Los Angeles District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
May 21, 2008 TriHerba Marketing [ARCHIVED] Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
May 21, 2008 Precision Herbs, L.L.C. [ARCHIVED] Cincinnati District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
May 21, 2008 Millennium Health LLC [ARCHIVED] Philadelphia District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
May 21, 2008 WallCann - Cura-Care.com [ARCHIVED] Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
May 20, 2008 Coral Calcium Factor [ARCHIVED] Seattle District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
May 20, 2008 Vitapurity Corporation [ARCHIVED] Seattle District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
May 20, 2008 JHS Natural products [ARCHIVED] Seattle District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
May 20, 2008 Best on Earth Products [ARCHIVED] San Francisco District Office Promotional Claims/False & Misleading N/A *
May 20, 2008 McPhail, Richard [ARCHIVED] Atlanta District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
May 20, 2008 Generation's Black Salve [ARCHIVED] San Francisco District Office New Drug/False Misleading Labeling N/A *
May 20, 2008 H & L Worldwide Inc. [ARCHIVED] Los Angeles District Office Promotional Claims False & Misleading/New Drugs N/A *
May 20, 2008 Hampton, Burt [ARCHIVED] Dallas District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
May 20, 2008 Ageless Cure, LLC [ARCHIVED] Dallas District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
May 19, 2008 Teeter Creek Herbs Company [ARCHIVED] Kansas City District Office Promotional Claims/False & Misleading/Misbranded N/A *
May 16, 2008 Mostel, Edward, M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
May 16, 2008 Western United Fish Company, Inc. [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
May 15, 2008 Steris Corporation [ARCHIVED] Cincinnati District Office Premarket Approval/Adulterated N/A *
May 15, 2008 Country Morning Farms [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
May 15, 2008 Sierra Providence Health Network IRB [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
May 14, 2008 Jer-Vic Inc., dba Foy's Pigeon Supplies [ARCHIVED] Philadelphia District Office CGMP/New Animal Drug Application/Adulterated/Misbranded N/A *
May 13, 2008 Central Connecticut Cooperative Farmers Association [ARCHIVED] New England District Office Animal Protein Feed/Equine/Adulterated N/A *
May 13, 2008 Rocky Top Dairy [ARCHIVED] Denver District Office Illegal Drug Residue N/A *
May 13, 2008 Vaqueria Paso Real [ARCHIVED] San Juan District Office Illegal Drug Residue N/A *
May 08, 2008 Mr. Seafood Distributors [ARCHIVED] Chicago District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
May 08, 2008 Elge, Inc. [ARCHIVED] Dallas District Office CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated N/A *
May 07, 2008 Blue Star Shrimp Company (dba Blue Star Seafood Inc.) [ARCHIVED] Florida District Office Seafood/HACCP/CGMP for Foods/Adulterated N/A *
May 07, 2008 Larson Medical Products, Inc. [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated N/A *
May 07, 2008 Legacy Pharmaceuticals International [ARCHIVED] San Juan District Office CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated N/A *
May 06, 2008 Advanced Orthopaedics of South Florida [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
May 06, 2008 Bella Cucina Artful Food, Inc. [ARCHIVED] Atlanta District Office Acidified Foods/Adulterated N/A *
May 05, 2008 Lakeview Dairy Farms [ARCHIVED] San Francisco District Office Illegal Drug Residue N/A *
May 02, 2008 Atlantic Southeast Airlines [ARCHIVED] Kansas City District Office Interstate Conveyance Sanitation Regulations/Provisional N/A *
May 02, 2008 Immucor, Inc. [ARCHIVED] Office of Enforcement CGMP Deviations N/A *
May 01, 2008 Nasim, Golzar MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *

 

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ICECI Warning Letters

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