Hill-Rom Inc. – FDA 483, Jul 29, 2022

An FDA inspection of Hill-Rom Inc. in Cary, NC, revealed significant deficiencies in their quality system, particularly concerning medical device reporting and complaint handling for their Voalte® Nurse Call System. The firm failed to submit MDR reports for multiple incidents, including two patient deaths and numerous malfunctions, and exhibited inadequate procedures for complaint evaluation and risk analysis. These issues indicate a serious lack of control over post-market surveillance and risk management processes.