1116352
Immersivetouch Inc — FEI 3014833795
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 29, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2602 | 21 CFR 820.30(d) | Design output - review and approval |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3672 | 21 CFR 820.30(c) | Design input - review and approval |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |