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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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2005 Warning Letters

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Tobacco Retailer Warning Letters

 

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Warning Letters issued in 2005

 

* 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 21, 2005 New England Marketers, Inc. dba Yankee Specialty Foods New England District Office Seafood HACCP/Adulterated N/A *
July 21, 2005 ACS Dobfar Center for Drug Evaluation and Research Current Good Manufacturing Practice Regulation/Adulterated N/A *
July 19, 2005 Uroplasty, Inc. Center for Devices and Radiological Health Sponsor Obligations N/A *
July 19, 2005 Beck Network, Inc. New Orleans District Office Promotional Claims False & Misleading/New Drugs N/A *
July 19, 2005 Pacific Northwest Best Fish Company Seattle District Office Seafood HACCP/Adulterated N/A *
July 19, 2005 SenoRx, Inc. Los Angeles District Office CGMP Requirements for medical devices/adulterated N/A *
July 18, 2005 Mercy Health System of Kansas, Inc. Kansas City District Office Current Good Manufacturing Practices for Blood and Blood Components N/A *
July 18, 2005 American Medical Specialties, Inc. Florida District Office Quality System Regulation for Medical Devices/Adulterated/Misbranded N/A *
July 13, 2005 Hitachi Medical Systems America, Inc. Cincinnati District Office Medical Device Reporting (MDR) Regulation Misbranded/Adulterated N/A *
July 11, 2005 Cape Drugs Center for Drug Evaluation and Research Pharmacy Compounding/New Drug/Misbranded N/A *
July 08, 2005 Holmes By-Products Company, Inc. Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded N/A *
July 07, 2005 Medical Science Products, Inc. Cincinnati District Office Quality System Reguation/Adulterated N/A *
July 07, 2005 Newport Seafoods Inc. Seattle District Office Seafood HACCP/Adulterated N/A *
July 06, 2005 Smith Dairy New Orleans District Office Illegal Drug Residue /Adulterated N/A *
July 06, 2005 Mark A. Mighell, M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
July 06, 2005 Mark A. Frankle, M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
July 06, 2005 Donald Pope Veal Farm Minneapolis District Office Illegal Drug Residue N/A *
July 06, 2005 Orthometrix, Inc. Center for Devices and Radiological Health Sponsor Obligations N/A *
July 01, 2005 Blake Street Manufacturing, LLC Denver District Office Food Labeling Misbranded N/A *
July 01, 2005 Litron Laboratories, Ltd Center for Drug Evaluation and Research GLP for non-clincal laboratory studies N/A *



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Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

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