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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 30, 2008 Kidron Auction Inc. [ARCHIVED] Cincinnati District Office Illegal Drug Residue N/A *
December 30, 2008 Dongkuk Techco Rubber Ind. Sdn Bhd [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Adulterated N/A *
December 24, 2008 Aunt Kitty's Foods, Inc. [ARCHIVED] New Jersey District Office Food Labeling Misbranded N/A *
December 24, 2008 Stoney Acres Calves [ARCHIVED] Detroit District Office Illegal Drug Residue N/A *
December 22, 2008 Troyer, Todd [ARCHIVED] Cincinnati District Office Illegal Drug Residue N/A *
December 22, 2008 Newman's Own Organics Center for Food Safety and Applied Nutrition N/A *
December 22, 2008 Columbia Presbyterian Medical Center [ARCHIVED] New York District Office Deviation/Adulterated N/A *
December 22, 2008 Newman's Own Organics [ARCHIVED] Center for Food Safety and Applied Nutrition Federal Food, Drug and Cosmetic Act/Misbranded N/A *
December 22, 2008 I-Flow Corporation [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
December 16, 2008 Ocean Beauty Seafoods, Inc. [ARCHIVED] Seattle District Office Seafood HACCP N/A *
December 16, 2008 Civic Center Pharmacy [ARCHIVED] Los Angeles District Office New Drug, Unapproved N/A *
December 15, 2008 Craig General Hospital [ARCHIVED] Dallas District Office Deviation from Good Manufacturing Practice N/A *
December 10, 2008 Savec Health Systems [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
December 10, 2008 High Tide Seafoods, Inc. [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
December 10, 2008 Coca-Cola Company (The) [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded N/A *
December 10, 2008 Virbac Inc. [ARCHIVED] Kansas City District Office CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded N/A *
December 08, 2008 RGI Medical Manufacturing, Inc. [ARCHIVED] Florida District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
December 05, 2008 Pneumex, Incorporated [ARCHIVED] Seattle District Office Premarket Approval/Misbranded/Adulterated N/A *
December 05, 2008 Douglas Bennett Farm [ARCHIVED] New England District Office Illegal Drug Residue N/A *
December 04, 2008 Haemonetics Corporation [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated N/A *



 

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