FDA Inspection 665439 — Elekta, Inc.
The FDA completed an inspection of Elekta, Inc. on May 21, 2010 in Atlanta, GA. 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
- May 21, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Atlanta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |