FDA 483 - Mi3 Limited - February 06, 2020

MI3 Limited, a medical device contract manufacturer in Blackburn, United Kingdom, was inspected by the FDA from February 3-6, 2020. The inspection revealed significant deficiencies in their quality system, particularly concerning process validation, corrective and preventive actions, risk analysis, and sampling plans. These issues indicate a lack of adequate controls to ensure the quality and safety of their manufactured medical devices, specifically the High Flow Insufflation Set.