FDA 483 - Gerard (nmi) Vockley, MD, PhD - January 29, 2020

An FDA inspection of Gerard Vockley, MD, PhD, a clinical investigator in Pittsburgh, PA, revealed two significant observations. The inspection found that not all changes in research activity were approved by an Institutional Review Board prior to implementation, specifically regarding subject weight restrictions. Additionally, an investigation was not conducted in accordance with the investigational plan, as one enrolled subject did not meet all specified inclusion criteria.