949595
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 1, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Warsaw, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |