1083206
Excel Medical Electronics LLC — FEI 3007472402
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 13, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Palm Bch Gdns, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3323 | 21 CFR 820.170(b) | Installer records |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |