FDA Inspection 1023134 — GS Medical Co., Ltd.
The FDA completed an inspection of GS Medical Co., Ltd. on August 10, 2017 in Cheongju. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 10, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cheongju (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |