FDA WARNING_LETTER - Trexo Robotics Holdings Inc. - June 05, 2023

An FDA inspection of Trexo Robotics Holdings Inc. in Mississauga, Ontario, Canada, from June 3-5, 2023, revealed significant violations regarding their Trexo Home and Trexo Plus medical devices, which are marketed in the U.S. The devices were found to be adulterated under Section 501(f)(1)(B) of the Act because the firm lacks an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE). They were also misbranded under Section 502(o) for failing to submit a premarket notification (510(k)) as required by 21 CFR 807.81. This is because the Trexo devices exceed exemption limitations due to their intended use as robotic gait training devices for children with disabilities and their different fundamental scientific technology, distinguishing them from legally marketed devices under 21 CFR 890.1925.

Additionally, the inspection identified four Quality System (QS) regulation violations under 21 CFR Part 820, rendering the devices adulterated under Section 501(h). These include failures to adequately establish and maintain procedures for: 1) design control (21 CFR 820.30(a)), 2) process validation (21 CFR 820.75(a)), 3) corrective and preventive action (21 CFR 820.100(a)(1)), and 4) complaint handling (21 CFR 820.198(a)). The firm's June 30, 2023, response to the FDA 483 observations was deemed inadequate for all QS violations. Trexo Robotics is required to cease misbranding/adulteration activities and provide a written response within fifteen business days detailing corrective actions, prevention plans, and implementation timelines to avoid further regulatory action, including seizure or injunction.