FDA Inspection 1316936 — Bionen S.R.L.
The FDA completed an inspection of Bionen S.R.L. on May 14, 2026 in Florence. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 14, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Florence (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 23135 | ISO 13485:2016 Clause 7.3.9 | Records of design and development changes and their reviews not maintained |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |