# FDA 483 - Nical S.p.A. - May 30, 2018

Source: https://www.globalkeysolutions.net/records/483/nical-spa/f0797792-9f79-431c-8baf-47d61cf2345e

> FDA 483 for Nical S.p.A. on May 30, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nical S.p.A.
- Inspection Date: 2018-05-30
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Nical S.p.A., a medical device manufacturer in Milan, Italy, revealed significant deficiencies in its quality system. The firm was cited for inadequate risk analysis, a lack of written medical device reporting procedures, and failures in its corrective and preventive action system. Additionally, procedures for device history records were found to be deficient, specifically regarding the inclusion of labeling.

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)

Company: https://www.globalkeysolutions.net/companies/nical-spa/0df1db78-7b7a-4e5b-ae9d-2b7a7b1afe16

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