FDA 483 - Amarex Clinical Research, LLC - December 29, 2021
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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.
ID · b91ae07d-9a97-463a-9ca0-968328c6ad61