Prof. Dimitar Shishkov, MDDecember 12, 2024

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

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Record Details

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.

Company: Prof. Dimitar Shishkov, MD
Inspection Date: December 12, 2024
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Richard W. Berning (Bioresearch Monitoring Foreign Inspection Cadre Member)

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