FDA 483 - Nezabravka Petrova Haytova - December 16, 2022

Nezabravka Petrova Haytova, a clinical investigator in Vratsa, Bulgaria, was cited with a Form FDA 483 following an inspection from December 12-16, 2022. The inspection revealed that an investigation was not conducted in accordance with the signed statement of investigator and investigational plan. Specifically, study staff compromised the confidentiality of electronic patient reported outcome (ePRO) application PIN codes by suggesting easily memorable numbers to subjects, including birth years.