FDA 483 - Labcorp Early Development Laboratories, Inc. - July 21, 2024

An FDA inspection conducted from July 8-12, 2024, at Labcorp Early Development Laboratories, Inc. in Greenfield, IN, identified significant deficiencies in adherence to Good Laboratory Practice (GLP) principles for nonclinical studies. The firm received a Form FDA 483 citing three primary observations, two of which were repeat findings from previous inspections, indicating persistent issues. A key concern was the study director's failure to ensure the timely archiving of essential study materials, including raw data, documentation, and specimens, after final reports were signed. Specific examples showed archiving delays ranging from 38 to 110 days post-report finalization. The Quality Assurance unit also failed to maintain an accurate master schedule sheet, with discrepancies noted in study statuses (e.g., studies marked "Open" despite signed final reports, or vice versa). Furthermore, final study reports were found to be incomplete, lacking identification of all involved scientists or professionals, specifically former study directors. These observations highlight a need for Labcorp Early Development Laboratories to strengthen its quality systems and operational controls to ensure compliance with the regulatory framework governing nonclinical laboratory studies. The company is expected to implement prompt corrective actions to address these findings and prevent recurrence, thereby upholding data integrity and regulatory standards.