710684
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 17, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mebane, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |
| 4208 | 21 CFR 806.20(a) | Records not kept |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |