FDA Inspection 1106208 — IMRIS Imaging Inc
The FDA completed an inspection of IMRIS Imaging Inc on October 1, 2019 in Chaska, MN. 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
- October 1, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Chaska, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 5907 | 21 CFR 1020.30(d)(1) | Report of assembly submitted within 15 days |