FDA 483 - Hoveround Corporation - March 07, 2025

During an FDA inspection, Hoveround Corporation, a medical device manufacturer in Bradenton, FL, was cited for significant deficiencies in its quality system. The firm failed to properly document corrective and preventive action (CAPA) activities and results. This lapse specifically pertained to addressing the root causes and corrective measures for untimely Medical Device Reporting (MDRs).