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

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.