FDA Inspection 1020085 — Bios S.r.l.
The FDA completed an inspection of Bios S.r.l. on July 13, 2017 in Vimodrone. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 13, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Vimodrone (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |