FDA EIR - Matthew J. Matasar, M.D. - March 22, 2019

The FDA conducted a high-priority, targeted surveillance inspection of Dr. Matthew J. Matasar, a clinical investigator based in New York, from March 18 to March 22, 2019. This inspection was part of the FY 2019 Bioresearch Monitoring (BIMO) Work Plan, under Compliance Program 7348.811, which focuses on clinical investigators and sponsor-investigators. It was initiated in accordance with an assignment memorandum from the Division of Good Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research (CDER).

This inspection was Dr. Matasar's first and aimed to evaluate compliance with protocols submitted under a Biologics License Application (BLA). The inspection identified several key areas of focus, including the authority and administration for studies involving human drugs, biologics, and devices, as well as the protocol for human drug, biologic, or device studies. The inspection also reviewed the Institutional Review Board processes, human subjects' records, and other study records.

The inspection revealed objectionable conditions, and management was required to respond to these findings. The report also noted that no refusals were encountered during the inspection. The FDA expects Dr. Matasar to address the identified issues and ensure compliance with regulatory standards to maintain the integrity of clinical research and safeguard human subjects involved in studies.