865762
Jeil Medical Corporation — FEI 3004049923
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 23, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Guro-gu, Seoul (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |