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Inspections, Compliance, Enforcement, and Criminal Investigations

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2008 Warning Letters

Warning Letters for 2008

Letter Issue Date Company Name Issuing Office Subject
December 30, 2008 Dongkuk Techco Rubber Ind. Sdn Bhd Center for Devices and Radiological Health CGMP/QSR/Adulterated
December 24, 2008 Aunt Kitty's Foods, Inc. New Jersey District Office Food Labeling Misbranded
December 24, 2008 Stoney Acres Calves Detroit District Office Animals for Sale for Slaughter as Food/Adulterated
December 22, 2008 Newman's Own Organics Center for Food Safety and Applied Nutrition Federal Food, Drug and Cosmetic Act/Misbranded
December 22, 2008 Newman's Own Organics Center for Food Safety and Applied Nutrition
December 22, 2008 I-Flow Corporation Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated
December 22, 2008 Columbia Presbyterian Medical Center New York District Office Deviation/Adulterated
December 16, 2008 Civic Center Pharmacy Los Angeles District Office New Drug, Unapproved
December 15, 2008 Craig General Hospital Dallas District Office Deviation from Good Manufacturing Practice
December 10, 2008 Savec Health Systems Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated
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