FDA Inspection 1116352 — Immersivetouch Inc
The FDA completed an inspection of Immersivetouch Inc on Jan 29, 2020 in Chicago, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 29, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: 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 |