FDA 483 - MEDTRONIC GRAND RAPIDS - December 15, 2025

An FDA inspection of Medtronic Grand Rapids, a medical device manufacturer, revealed significant deficiencies in environmental control procedures and the corrective and preventive action (CAPA) system. Observations included an unqualified clean room with an out-of-specification air change rate, inadequate and incomplete risk assessments for clean rooms, and improper personnel gowning and hygiene practices. Furthermore, the firm failed to escalate microbiological nonconformances into CAPAs and did not adequately document periodic reviews of environmental monitoring data.