558670
Mako Surgical Corporation — FEI 3005985723
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 21, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Weston, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |