FDA Inspection 1020606 — Diotech Co. Ltd.
The FDA completed an inspection of Diotech Co. Ltd. on July 28, 2017 in Busan. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 28, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Busan (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 14717 | 21 CFR 820.30(g) | Design validation - software validation documentation |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3837 | 21 CFR 820.25(b) | Training records |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5032 | 21 CFR 1010.2(b) | Certification label or tag |
| 5197 | 21 CFR 1040.10(h)(1)(i) | User information, adequate instructions |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |