FDA Inspection 1328564 — BIOPSYBELL S.R.L.
The FDA completed an inspection of BIOPSYBELL S.R.L. on Jul 23, 2026 in Mirandola. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jul 23, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mirandola (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |