FDA 483 - Labcorp Early Development Laboratories, Inc. - August 20, 2018

An FDA inspection of Covance Laboratories, Inc. in Madison, WI, from August 20-24, 2018, revealed a significant issue with data integrity and quality control. The firm failed to adhere to its established criteria for run acceptance, specifically by accepting and then unjustifiably rejecting chromatographic results during method validation. This indicates a breakdown in laboratory control procedures.