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

Source: https://www.keypedia.com/records/483/fona-srl/293d56e0-7d79-4b4f-94f0-c8ed6b8853a9

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

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## Details

- Record Type: 483
- Company Name: FONA S.R.L.
- Inspection Date: 2023-05-19
- Product Type: devices
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of FONA S.R.L., a Class II medical device manufacturer located in Assago, Milan, Italy, was conducted from May 15-19, 2023. The inspection resulted in an FDA Form 483, detailing eight significant observations related to the company's quality management system and electronic product radiation control compliance. Key issues included inadequate procedures for design changes, especially concerning software/firmware, and the absence of established statistical techniques for process capability and product quality, such as validated sampling plans. Deficiencies were also noted in procedures for receiving and evaluating customer complaints, and for the rework of nonconforming products, lacking proper justification, instructions, and data. Furthermore, the company's procedures for device history records and corrective and preventive actions (CAPA) were deemed insufficient, with the CAPA system missing requirements for effectiveness checks prior to closure. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, FONA S.R.L. also failed to base product certification on appropriate testing and good manufacturing practices, and did not provide purchasers with necessary maintenance schedules to ensure ongoing compliance with radiation safety regulations. The company is now required to address these deficiencies by submitting a comprehensive response outlining corrective actions to achieve full regulatory compliance.

## Related Documents

- [483 - 2023-05-19](https://www.keypedia.com/records/483/fona-srl/5298ac6b-c634-4907-8a1a-ce8b8fb9465e)

## 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/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64