FDA 483 - FONA S.R.L. - May 19, 2023

FONA S.R.L., a Class II device manufacturer in Assago, Milan, Italy, was inspected by the FDA from May 15-19, 2023. The inspection revealed significant deficiencies across its quality system, including inadequate procedures for design change, statistical techniques, complaint handling, rework, device history records, and corrective and preventive actions. Additionally, issues were noted with product certification testing and the provision of maintenance schedules to purchasers for their X-ray systems.