FDA Inspection 1118348 — GBS Commonwealth Co., Ltd.
The FDA completed an inspection of GBS Commonwealth Co., Ltd. on Feb 20, 2020 in Geumcheon. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 20, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Geumcheon (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3837 | 21 CFR 820.25(b) | Training records |