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

During an inspection conducted from April 29 to May 7, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Labcorp Early Development Laboratories, Inc. The observations highlight significant concerns regarding adherence to Good Laboratory Practice (GLP) principles, particularly concerning data management and archiving. The primary issue identified was the study director's failure to ensure the timely and complete transfer of all raw data, documentation, and reports to the company's archives upon study closure. Specifically, for a particular study, raw data was archived after the final study report was signed, indicating a lapse in the required process. Furthermore, the inspection revealed that essential Quality Control (QC) performance and review of Immunology and Immunotoxicity (I&I) raw data were not conducted prior to the study's closure. This critical I&I data was consequently not submitted to the archival unit and remains unarchived, lacking the necessary QC review. These observations indicate a deviation from internal standard operating procedures and regulatory expectations for GLP studies, which mandate thorough data integrity and comprehensive archiving. Labcorp Early Development Laboratories, Inc. is expected to address these findings by implementing corrective actions to ensure proper data handling, quality control review, and archiving procedures are consistently followed for all studies.