FDA 483 - Labcorp Clinical Research Unit, Inc. - October 07, 2022

Covance Cru Inc in Madison, WI, was cited for failing to conduct investigations in accordance with the signed statement of investigator and investigational plan during a bioequivalence study. Specifically, the firm did not report an identified autoinjector device defect, a black particle, to the sponsor as required by the study protocol and sponsor agreement. This indicates a deviation from established procedures for handling product complaints.