FDA Inspection 800237 — Kyungwon Medical Co., Ltd.
The FDA completed an inspection of Kyungwon Medical Co., Ltd. on September 20, 2012 in Osong-eup. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 20, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Osong-eup (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |