FDA WARNING_LETTER - Vasyl Melnyk, M.D. - September 14, 2021

This Warning Letter, Ref.: 21-HFD-45-12-01, dated January 4, 2022, was issued to Dr. Melnyk following an FDA inspection of their clinical site in Kyiv, Ukraine, from September 13 to September 14, 2021. The inspection, conducted by Investigator Tawny L. Colling, reviewed the conduct of a clinical investigation for (b)(4) as part of FDA’s Bioresearch Monitoring Program.

The primary violation identified was the failure to retain records required under 21 CFR 312.62(c). Specifically, for Protocol (b)(4), Dr. Melnyk failed to retain adequate and accurate case histories, including records of drug disposition, dates, quantity, and subject use, and complete case histories for subjects. These records were required to be retained because a Biologics License Application had been filed for the indication under study, and its outcome was pending.

During the inspection, Dr. Melnyk stated that all study records were stored in a locked archival room with limited access. However, on August 2, 2021, the sponsor’s contract research organization found study records missing. Dr. Melnyk explained that a departmental reorganization might have contributed to the missing records, despite staff being the only ones with access to the archival room. Dr. Melnyk also noted not being involved in clinical research since