1098393
Medical Informatics Corp. — FEI 3010392999
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 2, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14717 | 21 CFR 820.30(g) | Design validation - software validation documentation |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |