FDA 483 - Devon Orthopaedic Implants LLC., - March 23, 2020

An FDA inspection of Devon MD LLC, a Specification Developer/Initial Importer in King Of Prussia, PA, revealed significant deficiencies in their quality system. The firm failed to maintain complaint files, establish written Medical Device Reporting (MDR) procedures, and implement procedures for receiving and evaluating complaints. Additionally, the inspection found a lack of procedures for identifying products throughout all stages of their lifecycle.