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Talk to a SpecialistTalk to a SpecialistDr. Devalingam Mahalingam failed to conduct clinical drug investigations in accordance with applicable FDA regulations and investigational plans, specifically violating 21 CFR 312.60 by not ensuring that investigational drugs were administered to subjects according to their assigned dose-level cohorts as required by the protocol. The FDA inspection, conducted between October 7-18, 2024, as part of the Bioresearch Monitoring Program, identified objectionable conditions across at least two clinical protocols that raised concerns about the protection of human subjects' rights, safety, and welfare. Despite the investigator's review of these findings and Dr. Mahalingam's written response in November 2024, the FDA determined the response was inadequate to address the fundamental violations of the investigational plan requirements.