FDA 483 - Petar Bilic, MD, PhD - March 21, 2025

An FDA inspection of Petar Bilic, MD, PhD, a clinical investigator in Zagreb, Croatia, revealed significant deficiencies in maintaining adequate and accurate case histories. The firm failed to ensure data integrity, with instances of conflicting centrifugation times, duplicate pharmacokinetic sampling records, and inadequate documentation of investigational product administration for multiple subjects. These findings indicate a severe lack of proper record-keeping practices during the conduct of the investigation.