# FDA 483 - Fidia Farmaceutici S.p.A. - November 10, 2016

Source: https://www.globalkeysolutions.net/records/483/fidia-farmaceutici-spa/7fd07162-c31b-4d3a-b6bb-575d3abbefba

> FDA 483 for Fidia Farmaceutici S.p.A. on November 10, 2016. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fidia Farmaceutici S.p.A.
- Inspection Date: 2016-11-10
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Fidia Farmaceutici S.p.A. in Abano Terme, Italy, a medical device manufacturer, revealed a significant repeat observation regarding inadequate statistical techniques. The firm failed to adequately establish procedures for identifying valid statistical techniques for process capability and product characteristics, specifically concerning the sampling of rubber stoppers and glass syringes. This indicates a serious lapse in quality control processes.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/christine-e-kelley/20dfe38c-3102-4e23-bfeb-1d6895e567a0)

Company: https://www.globalkeysolutions.net/companies/fidia-farmaceutici-spa/2fbf69a2-721e-43f3-b41e-96d868382b45

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