# FDA 483 - Bionen S.r.l. - February 20, 2020

Source: https://www.keypedia.com/records/483/bionen-srl/46a6e600-3a82-4e2c-bdc1-d6ec408068c5

> FDA 483 for Bionen S.r.l. on February 20, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bionen S.r.l.
- Inspection Date: 2020-02-20
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Bionen S.A.S. in Firenze, Italy, received two observations during an FDA inspection concerning the manufacturing of medical devices, specifically needle electrodes for Botox injection. The inspection revealed deficiencies in adequately validating the sensor assembly and pouch sealing processes, as well as failures in establishing adequate procedures for investigating and evaluating complaints for MDR reportability.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.keypedia.com/companies/bionen-srl/e90dd311-b1cd-493e-a833-0f1ed916ae20

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