FDA 483 - Labcorp Early Development Laboratories, Inc. - July 12, 2024

Labcorp Early Development Laboratories, Inc. in Greenfield, IN, was cited with three observations during an FDA inspection of its nonclinical laboratories. The inspection revealed significant issues with Good Laboratory Practice, including the study director's failure to ensure timely archiving of study materials and the quality assurance unit's failure to maintain an accurate master schedule. Additionally, final study reports omitted the names of all involved scientists, and two of the observations were repeats from a previous inspection, indicating persistent non-compliance.