FDA 483 - Foresite Healthcare LLC - February 13, 2025

An FDA inspection conducted at Foresite Healthcare LLC from February 11-13, 2025, identified significant deficiencies related to quality system compliance for its DS6 depth sensor device. The inspection revealed that the company failed to promptly review, evaluate, and investigate complaints concerning undetected patient falls, despite receiving 218 such reports since January 2024, many of which may be reportable as Medical Device Reports (MDRs). A major concern highlighted was the absence of essential quality system procedures and instructions, indicating non-compliance with 21 CFR Part 820. Foresite Healthcare has not developed critical procedures for internal quality system audits, employee training, Corrective and Preventive Actions (CAPA), risk analysis, design review, rework, device history records, label control, and complaint handling. Furthermore, the company's Model DS6 device, a Class II medical device containing a Class 1 laser, was found to have an incomplete listing of laser components and was not registered with the FDA Center for Devices and Radiological Health. To address these issues, Foresite Healthcare is required to establish robust complaint handling processes, implement a comprehensive quality system in accordance with regulatory requirements, and ensure proper registration of all medical devices and their components.