# FDA 483 - Prof. Dimitar Shishkov, MD - October 20, 2023

Source: https://www.keypedia.com/records/483/prof-dimitar-shishkov-md/f94311a3-ba85-4894-96da-eb087414b964

> FDA 483 for Prof. Dimitar Shishkov, MD on October 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prof. Dimitar Shishkov, MD
- Inspection Date: 2023-10-20
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Dimitar Shishkov, MD, a clinical investigator in Plovdiv, Bulgaria, revealed a significant deviation from clinical trial protocols. The investigation was not conducted in accordance with the signed statement of investigator and investigational plan. Specifically, study subjects received Investigational Products from incorrect kits, indicating a failure to ensure proper randomization and administration.

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Company: https://www.keypedia.com/companies/prof-dimitar-shishkov-md/12967f9e-6876-4afb-bbd4-7b48653d886f

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd