# FDA 483 - Prof. Marek Hus - May 09, 2025

Source: https://www.keypedia.com/records/483/prof-marek-hus/2c4ffd78-efb9-4e93-b36c-3312cb6787f2

> FDA 483 for Prof. Marek Hus on May 09, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prof. Marek Hus
- Inspection Date: 2025-05-09
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Prof. Marek Hus, a clinical investigator in Lublin, Poland, was cited for failing to adhere to an investigational plan during a clinical study. The inspection revealed multiple instances where subject dosing was not re-calculated according to protocol requirements, specifically concerning body weight changes. This indicates a significant deviation from the study's established procedures for patient treatment.

## 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/prof-marek-hus/70bf6a5a-1acd-46bf-aeee-4ac7151b355f

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