1086408
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 10, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mc Lean, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |