738396
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 4, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Suwanee, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |