FDA Inspection 811881 — GS Medical Co., Ltd.
The FDA completed an inspection of GS Medical Co., Ltd. on December 13, 2012 in Cheongju. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 13, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Cheongju (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |