FDA 483 - Invacare Corporation - March 30, 2023

An FDA inspection of Invacare Corporation in Elyria, OH, a medical device manufacturer, revealed two significant observations. The firm's risk analysis for its Aviva Storm RX power wheelchair was found to be inadequate and incomplete, failing to include known hazards and accurately assess harm severity from complaints. Additionally, procedures for purchasing controls were not adequately established, leading to the continued use of suppliers that had been identified for disqualification.