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

An FDA inspection of Luis Pena-Hernandez, MD, a clinical investigator in Boynton Beach, FL, revealed significant deficiencies in the conduct of a clinical study. Observations included operating without proper IRB continuing review approval, enrolling a subject who did not meet inclusion criteria, and failing to maintain adequate case histories with complete data. These findings indicate a lack of adherence to regulatory requirements for clinical investigations.