FDA 483 - Medtronic Navigation, Inc. - June 29, 2021

An FDA inspection of Medtronic Navigation, Inc. in Louisville, CO, revealed significant deficiencies in their quality system. The firm failed to revalidate processes after changes, particularly concerning a supplier's process for biopsy needle depth stops, which led to a product recall. Additionally, risk analyses were found to be inadequate, and corrective and preventive action procedures were not adequately established or followed.