Medtronic Navigation, Inc. – FDA 483, Feb 9, 2024

An FDA inspection of Medtronic Navigation, Inc. in Lafayette, CO, revealed significant quality system deficiencies, particularly in corrective and preventive actions (CAPA), design verification, and purchasing controls. The firm failed to adequately establish CAPA procedures, leading to ineffective investigations and software releases prior to corrective action completion, and also had inadequate design verification documentation. Additionally, the firm did not qualify a contracted entity for software design control assessment, and this is a repeat observation regarding CAPA from a previous inspection.