FDA 483 - Foresite Healthcare LLC - February 13, 2025

An FDA inspection of Foresite Healthcare LLC in Maryland Heights, MO, revealed significant deficiencies in its quality system and complaint handling processes for its DS6 depth sensor device. The firm failed to promptly review and investigate MDR-reportable complaints, lacked essential quality system procedures, and did not register its laser-containing medical device with the FDA. These issues indicate a serious lack of control over device manufacturing and post-market surveillance.