FDA 483 - Luis Pena-Hernandez, M.D. - January 23, 2023

An FDA inspection conducted at Luis Pena-Hernandez, MD, a clinical investigator site in Boynton Beach, FL, from January 9 to January 23, 2023, identified significant deficiencies in the conduct of a clinical study. The observations noted indicate a failure to comply with established regulatory requirements for clinical investigations. Primary issues included operating a clinical study for approximately 55 days without a valid Institutional Review Board (IRB) continuing review approval, impacting three of four active subjects. Additionally, the inspection revealed that the study protocol was not strictly followed, as one enrolled subject did not meet a specified inclusion criterion for being on a particular treatment. The firm also failed to maintain adequate case histories, with missing completion dates for various assessment scales and procedures across all four enrolled subjects. These findings highlight a need for corrective actions to ensure proper oversight of clinical trials, strict adherence to study protocols, and thorough documentation, as mandated by FDA regulations governing clinical research. The firm is expected to address these observations to ensure future compliance.