FDA Inspection 839087 — Brainlab SE
The FDA completed an inspection of Brainlab SE on Jun 21, 2013 in Munich. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 21, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Munich (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |