FDA Inspection 1136833 — UltraLinq Healthcare Solutions Inc
The FDA completed an inspection of UltraLinq Healthcare Solutions Inc on Mar 11, 2021 in Morrisville, NC. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 11, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Morrisville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |