483
Vasyl MelnykFDA 483 - Vasyl Melnyk - September 14, 2021
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Record Details
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.
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ID · 8ec0304f-2b45-40b4-9b78-34835cd559b7