1101815
Interojo Inc. — FEI 3004146030
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 29, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pyeongtaek City (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 21425 | 21 CFR 820.184(f) | DHR - UDI not included |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |