751672
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 28, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lakewood, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |