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Dr. Shirish M. Gadgeel, a clinical investigator in Detroit, Michigan, failed to conduct drug clinical investigations in accordance with investigational plans and applicable FDA regulations governing human subject protection. During a Bioresearch Monitoring Program inspection conducted in August 2024, FDA identified that Dr. Gadgeel did not ensure subjects met eligibility criteria before enrollment in at least one protocol and failed to adhere to the investigational plan requirements under 21 CFR 312.60. The inspection covered three separate investigational drug protocols, and despite Dr. Gadgeel's September 2024 response to the inspection findings, the violations remained unresolved.