739588
BioSculptor Corporation — FEI 1000560772
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 16, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hialeah, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 5670 | 21 CFR 1040.10(h)(2)(ii) | Reproductions of warnings |