921780
Dexcowin Co. Ltd. — FEI 3007065358
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 26, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Geumcheon (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3837 | 21 CFR 820.25(b) | Training records |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |
| 5910 | 21 CFR 1020.30(h)(1)(ii) | Maintenance schedule (all x-ray eqpt) |