FDA 483 - Insightec, Inc - March 28, 2025

An FDA inspection of Insightec, Inc. in Dallas, TX, revealed significant deficiencies in the conduct of an investigational study. The firm failed to ensure proper monitoring of clinical research sites, leading to delayed monitoring reports. Additionally, the sponsor did not ensure that reviewing Institutional Review Boards (IRBs) were promptly informed of new safety information concerning study participants.