FDA 483 - Hill-Rom Inc - November 19, 2021

Hill-Rom, Inc. in Batesville, IN, was cited for significant deficiencies in its quality system related to complaint handling and nonconforming product control. The inspection revealed that the firm failed to adequately investigate device complaints, often relying on insufficient prior investigations. Additionally, procedures for managing nonconforming materials did not define when investigations were necessary for newly identified defect types, posing potential risks to device quality and patient safety.