FDA Inspection 803507 — Bien-Air Surgery SA
The FDA completed an inspection of Bien-Air Surgery SA on September 6, 2012 in Le Noirmont. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 6, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Le Noirmont (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3333 | 21 CFR 820.184(f) | Device identification, control numbers |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |