FDA Inspection 1003704 — Elekta Inc
The FDA completed an inspection of Elekta Inc on Feb 10, 2017 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
- Feb 10, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Saint Charles, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3346 | 21 CFR 820.200(b) | Analyzing service report |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |