FDA 483 - Labcorp Early Development Laboratories, Inc. - August 12, 2022

An FDA inspection of Labcorp Drug Development in Greenfield, IN, a nonclinical laboratory, revealed multiple significant deficiencies. The firm failed to properly authorize and document deviations from standard operating procedures, exhibited inadequate quality assurance oversight, and lacked sufficient written procedures for various laboratory operations. Issues also included incomplete personnel training records, inaccurate master schedule entries, and insufficient control over test and control articles.