1022432
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 17, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lakeland, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |