1015063
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 8, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Zhongshan (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |