861127
Adept Medical Ltd — FEI 3006098219
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 4, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Auckland (New Zealand)
Citations
| ID | CFR | Description |
|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |