FDA Inspection 631146 — B. Braun Avitum AG
The FDA completed an inspection of B. Braun Avitum AG on Nov 19, 2009 in Glandorf. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Nov 19, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Glandorf (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3276 | 21 CFR 820.80(e) | Maintained as part of the DHR {see also 820.184} |
| 3687 | 21 CFR 820.100(a)(1) | Analysis of data sources |
| 3693 | 21 CFR 820.100(a)(5) | Implementing changes |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |