FDA Inspection 1148417 — Intuitive Imaging Informatics LLC
The FDA completed an inspection of Intuitive Imaging Informatics LLC on August 6, 2021 in Bell Canyon, CA. 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) (VAI)
- End Date
- August 6, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bell Canyon, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 21424 | 21 CFR 820.120(b) | Labeling inspection - UDI |
| 3696 | 21 CFR 820.100(b) | Documentation |