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

Source: https://www.keypedia.com/records/483/petar-bilic-md-phd/41a24b42-2070-4642-a22d-85403189d8a9

> FDA 483 for Petar Bilic, MD, PhD on March 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Petar Bilic, MD, PhD
- Inspection Date: 2025-03-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [Bioresearch Monitoring Foreign Inspection Cadre Member](https://www.keypedia.com/people/richard-w-berning/4637e321-8803-4fcf-911f-bbc810c3487d)

Company: https://www.keypedia.com/companies/petar-bilic-md-phd/e4ae4ff2-8ca3-4b7e-8307-4f6db78c5ac4

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8