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

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.