FDA Inspection 819441 — Alien Technik
The FDA completed an inspection of Alien Technik on February 7, 2013 in Hronov 1. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 7, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hronov 1 (Czech Republic)
Citations
| ID | CFR | Description |
|---|---|---|
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |