FDA Inspection 1226484 — STG24 CO.,LTD.
The FDA completed an inspection of STG24 CO.,LTD. on Dec 14, 2023 in Namdong. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 14, 2023
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Namdong (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 2431 | 21 CFR 820.30(b) | Design plans- updated |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |