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

Labcorp Early Development Laboratories, Inc. in Madison, WI, received a Form 483 for a significant Good Laboratory Practice (GLP) violation. The inspection revealed that the study director failed to ensure the proper transfer of all raw data, documentation, and reports to the archives at the close of a study. This included a failure to perform required Quality Control (QC) review on immunology and immunotoxicity data before its submission to the archival unit.