FDA Inspection 1050218 — Shin Chang Medical Co., Ltd.
The FDA completed an inspection of Shin Chang Medical Co., Ltd. on Apr 26, 2018 in Gumi. 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). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 26, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Gumi (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |