FDA Inspection 872536 — B. Braun Surgical, S.A.
The FDA completed an inspection of B. Braun Surgical, S.A. on March 20, 2014 in Rubi. 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
- March 20, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rubi (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 648 | 21 CFR 803.18(e) | MDR not evaluated per 820.198 |