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Dr. Luis Javier Pena-Hernandez was cited for failing to conduct a clinical drug investigation in accordance with applicable regulations and the investigational protocol during an FDA inspection conducted in January 2023. Specifically, he failed to ensure that study subjects met all inclusion criteria before enrollment, violating 21 CFR 312.60 requirements that clinical studies be conducted according to the investigational plan. The inspection was part of FDA's Bioresearch Monitoring Program, which evaluates whether human subjects' rights, safety, and welfare are adequately protected during clinical research.