1116473
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 23, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Oldsmar, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 5008 | 21 CFR 1002.20(a) | Failure to report |