# FDA 483 - Frantisek Duska, M.D. - August 22, 2025

Source: https://www.globalkeysolutions.net/records/483/frantisek-duska-md/e4047880-01a1-4a7c-9374-204480719b51

> FDA 483 for Frantisek Duska, M.D. on August 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Frantisek Duska, M.D.
- Inspection Date: 2025-08-22
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Frantisek Duska, M.D., a clinical investigator in Prague, Czechia, revealed significant deficiencies in the conduct of study protocol 995 AdFirst. Observations included failures to maintain complete source documentation for adverse events and to report some adverse events, as well as incorrect calculation of blood loss as outlined in the investigational plan. These findings indicate a lack of adherence to proper clinical trial practices.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/lori-gioia/34b9339b-0bd2-4e41-8da1-b445ad829e53)

Company: https://www.globalkeysolutions.net/companies/frantisek-duska-md/99f6efde-53fd-4289-87f7-7d8e9b3f0894

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