FDA 483 - Labcorp Early Development Laboratories, Inc. - August 19, 2010

An FDA inspection of Covance Laboratories Inc. in Madison, WI, a GLP laboratory, revealed significant deviations from standard operating procedures during a study. These deviations included unauthorized changes and inconsistent data reporting for bioanalytical determinations, as well as improper timing for in-life dose administrations. The findings indicate a failure to adhere to established protocols and proper documentation practices.