647781
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 22, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Saint Charles, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3370 | 21 CFR 820.198(a)(2) | Oral complaints |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |