FDA Inspection 852382 — IBA Dosimetry GmbH
The FDA completed an inspection of IBA Dosimetry GmbH on Sep 13, 2013 in Schwarzenbruck. 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
- Sep 13, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Schwarzenbruck (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |