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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
May 20, 2008 H & L Worldwide Inc. Los Angeles District Office Promotional Claims False & Misleading/New Drugs N/A *
May 19, 2008 Teeter Creek Herbs Company Kansas City District Office Promotional Claims/False & Misleading/Misbranded N/A *
May 16, 2008 Mostel, Edward, M.D. Center for Drug Evaluation and Research Clinical Investigator N/A *
May 16, 2008 Western United Fish Company, Inc. Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
May 15, 2008 Country Morning Farms Seattle District Office Illegal Drug Residue N/A *
May 15, 2008 Steris Corporation Cincinnati District Office Premarket Approval/Adulterated N/A *
May 15, 2008 Sierra Providence Health Network IRB Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
May 14, 2008 Jer-Vic Inc., dba Foy's Pigeon Supplies Philadelphia District Office CGMP/New Animal Drug Application/Adulterated/Misbranded N/A *
May 13, 2008 Central Connecticut Cooperative Farmers Association New England District Office Animal Protein Feed/Equine/Adulterated N/A *
May 13, 2008 Rocky Top Dairy Denver District Office Illegal Drug Residue N/A *
May 13, 2008 Vaqueria Paso Real San Juan District Office Illegal Drug Residue N/A *
May 08, 2008 Mr. Seafood Distributors Chicago District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
May 08, 2008 Elge, Inc. Dallas District Office CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated N/A *
May 07, 2008 Legacy Pharmaceuticals International San Juan District Office CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated N/A *
May 07, 2008 Blue Star Shrimp Company (dba Blue Star Seafood Inc.) Florida District Office Seafood/HACCP/CGMP for Foods/Adulterated N/A *
May 07, 2008 Larson Medical Products, Inc. Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated N/A *
May 06, 2008 Advanced Orthopaedics of South Florida Center for Devices and Radiological Health Clinical Investigator (Sponsor) N/A *
May 06, 2008 Bella Cucina Artful Food, Inc. Atlanta District Office Acidified Foods/Adulterated N/A *
May 05, 2008 Lakeview Dairy Farms San Francisco District Office Illegal Drug Residue N/A *
May 02, 2008 Atlantic Southeast Airlines Kansas City District Office Interstate Conveyance Sanitation Regulations/Provisional N/A *



 

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ICECI Warning Letters

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