FDA 483 - Labcorp Early Development Laboratories, Inc. - April 11, 2025

An FDA inspection of Labcorp Early Development Laboratories, Inc. in Greenfield, IN, a nonclinical laboratory, revealed significant deficiencies in Good Laboratory Practices. Observations included failures in accurately recording experimental data, inadequate equipment inspection and maintenance, and a lack of established standard operating procedures for handling test and control articles. These issues indicate potential systemic problems in ensuring data integrity and operational quality.