FDA 483 - Medtronic MiniMed, Inc. - March 10, 2023

An FDA inspection of Medtronic MiniMed, Inc. in Northridge, CA, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for complaint handling, corrective and preventive actions, and environmental controls in their cleanroom. These issues indicate a moderate to severe level of non-compliance impacting medical device manufacturing.