672519
Peregrine Surgical Ltd — FEI 1000121498
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 15, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New Britain, PA (United States)
Citations
| ID | CFR | Description |
|---|
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 2910 | 21 CFR 812.7(a) | Promotion or test marketing |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |