FDA 483 - InSightec, Ltd. - November 30, 2017

InSightec, Ltd., a medical device manufacturer in Tirat Carmel, Hefa, Israel, received two observations during an FDA inspection. The firm's medical device reporting (MDR) procedure was found to be inadequate, leading to a failure to report two serious injury events. Additionally, their corrective and preventive action (CAPA) procedures were not adequately established, specifically lacking verification of effectiveness.