699614
BioSculptor Corporation — FEI 1000560772
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 30, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Hialeah, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3343 | 21 CFR 820.198(e) | Maintained |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |