FDA 483 - Trexo Robotics Holdings Inc. - June 08, 2023

Trexo Robotics Holdings Inc., a medical device manufacturer, underwent an FDA inspection from June 5 to June 8, 2023. The inspection resulted in four significant observations, highlighting critical deficiencies in the company's quality management system. The main issues included inadequate procedures for design validation for their Trexo Home and Trexo Plus devices, failing to ensure proper verification and validation before distribution. Furthermore, processes whose results cannot be fully verified by subsequent inspection and test, such as certain critical testing, were not adequately validated according to established procedures.

Additional observations pointed to an insufficient corrective and preventive action (CAPA) system, where all data sources, including non-conformance reports, were not consistently reviewed for potential CAPAs. Crucially, the firm's procedures for handling complaints were also found to be inadequate. Many complaints were misclassified as 'feedback,' potentially bypassing necessary evaluations for Medical Device Reporting (MDRs), and documentation regarding complaint investigations, even when not required, was incomplete. Trexo Robotics Holdings Inc. has committed to correcting all identified observations to ensure compliance with medical device quality system requirements.