FDA Inspection 1167421 — U Deliver Medical LLC
The FDA completed an inspection of U Deliver Medical LLC on Apr 19, 2022 in Hopkins, MN. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 19, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hopkins, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |