Astura Medical – FDA 483, Apr 23, 2026

An FDA inspection of Astura Medical in Irving, TX, a specification developer of Class 2 spinal implants, revealed significant deficiencies across its quality system. Observations included inadequate documentation for design and development changes, insufficient validation of cleaning processes, and a failure to monitor supplier performance. Additionally, the firm's complaint handling procedures were found to be incomplete, and information from the feedback process was not adequately integrated into risk management activities.