FDA Inspection 1111836 — Umano Medical, Inc.
The FDA completed an inspection of Umano Medical, Inc. on December 4, 2019 in L'Islet. 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
- December 4, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- L'Islet (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 21425 | 21 CFR 820.184(f) | DHR - UDI not included |
| 3168 | 21 CFR 820.198(a) | Complaints |