FDA 483 - Vasyl Melnyk - September 14, 2021

An FDA inspection of Vasyl Melnyk, a clinical investigator in Kyiv, Ukraine, revealed a significant issue with record retention. The firm failed to retain investigational records for a period of two years following the approval of a drug's marketing application. This included critical documents such as signed informed consent forms, medical history, and other study-related records for a Phase 2 clinical trial.