FDA Inspection 733070 — Sewoon Medical Co., Ltd.
The FDA completed an inspection of Sewoon Medical Co., Ltd. on Jun 23, 2011 in Cheonan. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 23, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cheonan (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |