# FDA 483 - Prof. Dimitar Shishkov, MD - December 12, 2024

Source: https://www.keypedia.com/records/483/prof-dimitar-shishkov-md/5ec5f06e-252e-439c-b25f-a4e55cd0ba83

> FDA 483 for Prof. Dimitar Shishkov, MD on December 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prof. Dimitar Shishkov, MD
- Inspection Date: 2024-12-12
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Prof. Dimitar Shishkov, MD, a clinical investigator in Plovdiv, Bulgaria, revealed significant issues with maintaining accurate case histories. Specifically, source documentation for multiple subjects contained conflicting or duplicated information regarding the administration of investigational product. These findings indicate a serious concern regarding data integrity in the clinical study.

## Related Documents

- [483 - 2023-10-20](https://www.keypedia.com/records/483/prof-dimitar-shishkov-md/f94311a3-ba85-4894-96da-eb087414b964)

## 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-dimitar-shishkov-md/12967f9e-6876-4afb-bbd4-7b48653d886f

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