Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistDr. Nana Barseghian failed to conduct clinical drug investigations in accordance with FDA regulations (21 CFR 312) during an inspection of her clinical site in February 2024. Specifically, she did not ensure that clinical studies were conducted according to their investigational plans, including a failure to verify that study subjects met all required eligibility criteria before enrollment in Protocol (b)(4). The inspection was part of the FDA's Bioresearch Monitoring Program, which evaluates whether the rights, safety, and welfare of human research subjects have been protected.