FDA Inspection 734877 — B. Braun Melsungen AG
The FDA completed an inspection of B. Braun Melsungen AG on Jun 17, 2011 in Melsungen. 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 17, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Melsungen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14717 | 21 CFR 820.30(g) | Design validation - software validation documentation |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |