FDA EIR - Covance Laboratories Inc. - August 19, 2010

An FDA Good Laboratory Practice (GLP) surveillance inspection was conducted at Covance Laboratories Inc., Madison, WI, from August 2 to August 19, 2010. The inspection, guided by Compliance Program 7348.808 (21 CFR Part 58), aimed to assess the firm's adherence to GLP regulations. The inspection revealed non-compliance issues, documented on a Form FDA 483. Main violations included the failure to authorize and document all deviations from standard operating procedures (SOPs) in raw data, specifically regarding inconsistent reporting of bioanalytical reassay results and deviations in timed study observations. Additionally, observations were made regarding employee practices and equipment storage that posed potential contamination risks during the formulation and dosing of test materials. Firm management committed to implementing corrections, with some actions already initiated before the inspection concluded.