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Bertrand P. Cole, D.O., a clinical investigator, was cited for failures in conducting clinical drug investigations in violation of 21 CFR 312 requirements. The FDA's inspection of his clinical site between May 12-16, 2025, identified that Dr. Cole failed to ensure investigations were conducted according to their investigational plans, specifically regarding the proper randomization of subjects across different drug dosage groups in at least one protocol. These violations occurred during the conduct of multiple investigational drug studies and compromised the protections required for human research subjects under FDA's Bioresearch Monitoring Program.