FDA 483 - Ulrich Medical USA Inc - March 17, 2025

Ulrich Medical USA Inc, a specification developer for spinal implants and instrumentation in Plano, TX, received one repeat observation during an FDA inspection. The firm's complaint handling procedures were found to be inadequate, specifically regarding the processing of complaints for parent company products and the identification of non-conformance trends. This indicates a recurring issue with the firm's quality system.