FDA Inspection 917902 — Transcoject GmbH
The FDA completed an inspection of Transcoject GmbH on Feb 19, 2015 in Neumunster. 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
- Feb 19, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Neumunster (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |