FDA 483 - Labcorp Early Development Laboratories, Inc. - May 07, 2025

An FDA inspection of Labcorp Early Development Laboratories, Inc. in Madison, WI, revealed a significant Good Laboratory Practice (GLP) deficiency. The study director failed to ensure the complete transfer of raw data, documentation, and reports, specifically Immunology and Immunotoxicity data, to the archives at the close of a study. This included a failure to perform required Quality Control on the data before archiving, indicating a lapse in regulatory compliance for data management.