FDA Inspection 1040004 — UltraLinq Healthcare Solutions Inc
The FDA completed an inspection of UltraLinq Healthcare Solutions Inc on Jan 30, 2018 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
- Jan 30, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Morrisville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |