FDA Inspection 1006562 — Ziehm Imaging Gmbh
The FDA completed an inspection of Ziehm Imaging Gmbh on Feb 17, 2017 in Nuremberg. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 17, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Nuremberg (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 5044 | 21 CFR 1010.3(a)(2) | ID label lacks place, month & year of manufacture |