FDA 483 - David J. De La Zerda, MD - January 13, 2021

David J. De La Zerda, MD, a clinical investigator in Miami, FL, received a Form FDA 483 for failing to conduct an investigation in accordance with the signed statement of investigator and investigational plan. The inspection revealed significant protocol violations across two studies, including subjects not completing required liver function tests, failing to meet inclusion/exclusion criteria, and receiving investigational product despite elevated liver enzymes or prohibited therapies. These findings indicate a serious lack of adherence to study protocols, which is a significant concern.