FDA Inspection 924849 — Corentec Co., LTD
The FDA completed an inspection of Corentec Co., LTD on Apr 9, 2015 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 9, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cheonan (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 4213 | 21 CFR 806.20(b)(5) | Records of communications |