FDA Inspection 909439 — Inkutec Gmbh
The FDA completed an inspection of Inkutec Gmbh on Dec 4, 2014 in Barsbuttel. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 4, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Barsbuttel (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 537 | 21 CFR 820.70(a) | Production processes |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |