FDA 483 - Asen Georgiev Medzhidiev - December 16, 2022

An FDA inspection of Asen Georgiev Medzhidiev, M.D., a clinical investigator in Sofia, Bulgaria, revealed a significant deviation from the investigational plan for a COVID-19 study. Site personnel failed to ensure participants created confidential device PIN codes, instead instructing them to use easily guessable birth years, compromising data integrity and participant privacy.