FDA 483 - Invacare Corporation - April 09, 2025

An FDA inspection of Invacare Corporation in Elyria, OH, a medical device manufacturer, revealed significant deficiencies in its quality system, with multiple repeat observations. The firm failed to adequately establish and follow procedures for risk analysis of power wheelchairs, maintain an approved supplier list, and properly handle customer complaints. These issues indicate a concerning lack of adherence to regulatory requirements, with potential implications for patient safety.