FDA 483 - Robin Cornelissen - April 08, 2022

During an inspection from April 4-8, 2022, the FDA observed that Robin Cornelissen, MD, a Principal Investigator in Rotterdam, Netherlands, failed to maintain accurate case histories. Specifically, the firm did not report numerous adverse events documented in subjects' source records for a clinical protocol. This indicates a significant lapse in clinical trial record-keeping and adverse event reporting.