FDA 483 - Foresite Healthcare LLC - February 13, 2025

An FDA inspection of Foresite Healthcare LLC in Maryland Heights, MO, revealed significant deficiencies in their quality system for the DS6 depth sensor device. The firm failed to promptly review and investigate MDR-reportable complaints concerning undetected patient falls. Additionally, Foresite Healthcare lacked established quality system procedures for critical areas such as internal audits, training, CAPA, and complaint handling, and had an incomplete listing of laser components for their Class II medical device, which was not registered with the FDA.