697275
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 10, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- West Plains, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |