FDA 483 - Amarex Clinical Research, LLC - December 29, 2021

An FDA inspection of Amarex Clinical Research, LLC, a Contract Research Organization in Germantown, MD, revealed significant deficiencies in clinical study monitoring. The firm failed to ensure proper oversight of studies, including the absence of a required Data Monitoring Committee for one study. Additionally, numerous on-site and remote monitoring visits were not conducted as scheduled, and many monitoring reports were finalized well beyond the required timeframe.