FDA 483 - Medtronic Navigation, Inc.-Boxborough - January 03, 2018

Medtronic Navigation, Inc.-Littleton, a medical device manufacturer in Littleton, MA, was cited for multiple significant quality system deficiencies during an FDA inspection. The firm failed to report field corrective actions, accidental radiation occurrences, and medical device reports (MDRs) in a timely manner. Additionally, the inspection revealed inadequate documentation of CAPA activities and a failure to submit required annual and product reports for their O-Arm imaging systems.