FDA Inspection 817938 — GEO Medical Co., Ltd.
The FDA completed an inspection of GEO Medical Co., Ltd. on Jan 31, 2013 in Buk. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 31, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Buk (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |