FDA 483 - Petar Bilic, MD, PhD

During an FDA inspection from March 17-21, 2025, Klinika za psihijatriju Vrapée, Zavod za psihotiéne poremec¢aje MuSki, was cited with a Form 483 for deficiencies in maintaining adequate and accurate case histories during a clinical investigation. The primary observation highlighted significant issues with source document integrity and conflicting information.

Key violations included overlapping centrifugation times for blood samples from five of fourteen enrolled subjects, suggesting potential data integrity issues in pharmacokinetic analysis. Additionally, duplicate pharmacokinetic sampling records were identified for four subjects, with discrepancies in recorded sample times or centrifugation details, and instances of identical duplicate forms. A critical concern was raised regarding the documentation of investigational product administration, where visit summary narratives for ten of fourteen subjects either lacked or incorrectly stated the product given, contradicting randomization schedules and accountability records. No other original documentation was available to confirm correct product administration.

These observations, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, represent initial inspectional findings. The firm is expected to address these conditions by discussing any objections or by implementing comprehensive corrective actions to ensure robust data accuracy and compliance with regulatory standards.