1013947
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 18, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Waikanae (New Zealand)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |