855042
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 12, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Loves Park, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2339 | 21 CFR 820.22 | Quality Audit/Reaudit - documentation |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |