FDA Inspection 1061600 — Intuitive Imaging Informatics LLC
The FDA completed an inspection of Intuitive Imaging Informatics LLC on July 26, 2018 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
- July 26, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Bell Canyon, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |