FDA 483 - Jacek Mackiewicz, MD, PhD - April 28, 2023

An FDA inspection of Jacek Mackiewicz, MD, PhD, a clinical investigator in Poznan, Poland, revealed a significant issue regarding the failure to maintain accurate case histories. Specifically, adverse events and concomitant medications for multiple subjects were not reported to the sponsor via case report forms until after the inspection was preannounced. This indicates a serious lapse in data reporting and record-keeping practices during a clinical study.