FDA Inspection 914851 — B. Braun Melsungen AG
The FDA completed an inspection of B. Braun Melsungen AG on Feb 19, 2015 in Melsungen. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 19, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Melsungen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |