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Dr. Ignacio J. Rodriguez, a clinical investigator in Hialeah, Florida, failed to conduct a drug clinical investigation in accordance with the investigational plan and applicable FDA regulations governing human subject protection. Specifically, he did not ensure that enrolled subjects met the study's inclusion and exclusion criteria before enrollment, did not verify that subjects met randomization criteria before randomization, and failed to conduct required study activities as specified in the protocol. These violations were identified during an FDA Bioresearch Monitoring Program inspection conducted between August 18 and September 29, 2020, which assessed his compliance with 21 CFR 312.60 and the protection of human research subjects.