FDA EIR - Labcorp Early Development Laboratories, Inc. - August 31, 2021

An FDA inspection of Labcorp Drug Development, Inc.'s Chantilly, Virginia facility (formerly Covance, Inc.) was conducted from August 25 to August 31, 2021. This preannounced, comprehensive surveillance inspection focused on the non-clinical laboratory's pathology review and digital imaging operations. It was performed under the Good Laboratory Practice (GLP) regulatory framework, specifically Compliance Program 7348.808 for non-clinical laboratories. This marked the initial FDA inspection for this specific site.

While no formal FDA-483 "Inspectional Observations" was issued, a key discussion item with management concerned discrepancies found in the firm's master schedule. Specifically, inconsistencies were noted regarding the listed locations of Principal Investigators for histology studies.

In response, Labcorp Drug Development management acknowledged these discrepancies, confirming the importance of accurate record-keeping. They committed to an internal investigation and the implementation of a Corrective and Preventive Action (CAPA) plan. This plan aims to verify the accuracy of Principal Investigator locations and other critical information within the master schedule and associated databases through random checks. Furthermore, the firm intends to review its Quality Assurance process for master schedule maintenance to ensure its robustness and adequacy. The inspection otherwise found no deviations in pathology review that impacted study conduct or interpretation.