FDA 483 - Conformis Inc. - January 13, 2026

An FDA inspection of Conformis Inc. in Wilmington, MA, revealed inadequate procedures for receiving, reviewing, and evaluating complaints. Specifically, a significant number of complaint files lacked the required Unique Device Identifier (UDI) or Universal Product Code (UPC) documentation. This indicates a notable deficiency in the firm's complaint handling system for its medical devices.