FDA 483 - Devon Orthopaedic Implants LLC., - May 18, 2022

An FDA inspection of Devon Orthopaedic Implants LLC. in King Of Prussia, PA, revealed significant deficiencies in the firm's quality system. The inspection identified failures in maintaining complaint files, establishing complaint handling procedures, developing Medical Device Reporting (MDR) procedures, and ensuring proper product identification. Several of these issues, including those related to complaint management and MDRs, were repeat observations, indicating persistent non-compliance with regulatory requirements for medical device manufacturing.