FDA EIR - Medpace Inc - August 27, 2019

A high-priority FDA surveillance inspection of Medpace Imaging Core Lab, a Contract Research Organization (CRO), was conducted in Cincinnati, OH, from August 26-27, 2019. This audit, requested by the Center for Drug Evaluation and Research (CDER), Office of Scientific Investigations, focused on the facility's compliance with regulations governing clinical studies under the Federal Food, Drug, and Cosmetic Act. The inspection specifically reviewed the conduct of Medpace Imaging Core Lab for a new molecular entity study, examining various documents such as organizational charts, standard operating procedures, study protocols, training records, and electronic subject scan results.

Crucially, at the conclusion of this comprehensive inspection, no Form FDA-483 was issued. This signifies that no objectionable conditions or significant regulatory violations were identified at Medpace Imaging Core Lab during this review period. Consequently, no specific corrective actions or remedial measures were required by the FDA from the company as a direct result of this inspection. The report noted that this inspection was distinct from a prior 2017 audit of Medpace CRO, which had cited issues regarding monitoring and non-compliant clinical investigators, but those prior findings were not subject to verification during this recent assessment of the Imaging Core Lab.