FDA Inspection 730299 — Elekta Inc
The FDA completed an inspection of Elekta Inc on Jun 17, 2011 in Saint Charles, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 17, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Saint Charles, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2602 | 21 CFR 820.30(d) | Design output - review and approval |
| 3696 | 21 CFR 820.100(b) | Documentation |