FDA 483 - ReNovo, Inc. - May 18, 2023

Renovo, Inc. in Bend, OR, was inspected by the FDA and received a Form FDA 483 with three observations. The inspection revealed deficiencies in establishing adequate procedures for controlling environmental conditions, managing non-conforming products, and ensuring adherence to equipment maintenance schedules for medical devices. These issues indicate potential quality system failures that could impact product quality and safety.