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

Source: https://www.keypedia.com/records/483/fona-srl/5298ac6b-c634-4907-8a1a-ce8b8fb9465e

> FDA 483 for FONA S.R.L. on May 19, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: FONA S.R.L.
- Inspection Date: 2023-05-19
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Cso](https://www.keypedia.com/people/daniel-j-lahar/d4e329c0-b6a5-42ca-acde-b79413b245ea)

Company: https://www.keypedia.com/companies/fona-srl/a5f2ae8b-a204-4a90-b9db-64ff869b4f26

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd