FDA 483 - Hoveround Corporation - June 14, 2019

Hoveround Corporation, a medical device manufacturer in Sarasota, FL, was cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures for corrective and preventive actions, including failures to update risk analyses for serious complaints, and a lack of standardized medical device reporting processes and documentation. Additionally, the firm's device history records were found to be incomplete.