FDA 483 - Viktor Vass, MD - September 13, 2019

Synexus Hungary Health Care Service Ltd., a clinical investigator in Budapest, was cited for failing to conduct an investigation in accordance with its investigational plan. The inspection revealed deficiencies in the timely reporting of serious adverse events (SAEs) to the study sponsor, as required by the protocol. This indicates a lapse in adherence to established clinical trial procedures for patient safety reporting.