# FDA 483 - Mattioli Engineering Italia SpA - August 30, 2018

Source: https://www.keypedia.com/records/483/mattioli-engineering-italia-spa/e2a0656a-0efd-4974-86dd-dfdafd39d1fb

> FDA 483 for Mattioli Engineering Italia SpA on August 30, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mattioli Engineering Italia SpA
- Inspection Date: 2018-08-30
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Mattioli Engineering Italia SpA, a medical device manufacturer in Calenzano, Italy, revealed two significant issues. The firm failed to adequately document design validation results for a Class 2 iontophoresis device and lacked written agreements with most suppliers and contractors for change notification. These findings indicate deficiencies in the firm's quality system.

## Related Documents

- [483 - 2018-08-27](https://www.keypedia.com/records/483/mattioli-engineering-italia-spa/85a57811-95bb-4cd2-b41f-2f5ed38752f2)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/paul-m-kawamoto/0a24b110-12de-4736-8d98-7a023ceec01e)

Company: https://www.keypedia.com/companies/mattioli-engineering-italia-spa/bd59e4e6-78e1-4fa9-80b2-000730ce7604

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