# FDA 483 - FIAB spa - May 16, 2024

Source: https://www.globalkeysolutions.net/records/483/fiab-spa/71436fb2-691f-4c5b-8dcd-478f2d330dd1

> FDA 483 for FIAB spa on May 16, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: FIAB spa
- Inspection Date: 2024-05-16
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: FIAB spa, a medical device manufacturer in Vicchio, Florence, Italy, was inspected by the FDA and received a Form 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate documentation of acceptance activities, poorly established purchasing procedures, insufficient maintenance of quality system records, and inadequate complaint handling procedures, specifically regarding Unique Device Identification (UDI) recording.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

Company: https://www.globalkeysolutions.net/companies/fiab-spa/51490577-8d3b-4c2f-b418-2fd8a652ef58

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