Medtronic Sofamor Danek USA, Inc – FDA 483, Feb 17, 2022

An FDA inspection of Medtronic Sofamor Danek USA, Inc. in Memphis, TN, a manufacturer of medical devices, revealed significant deficiencies in their quality system. Observations included inadequate procedures for corrective and preventive actions, complaint handling, device history records, process controls, and equipment calibration. These issues indicate a lack of robust controls over critical manufacturing and quality processes.