FDA Inspection 1195305 — UniSoft Medical Corporation
The FDA completed an inspection of UniSoft Medical Corporation on Jan 19, 2023 in Torrington, CT. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jan 19, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Torrington, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 21425 | 21 CFR 820.184(f) | DHR - UDI not included |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |