1019463
Inventex Medical — FEI 3009495876
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 27, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Niles, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4437 | 21 CFR 803.40(b) | Report of malfunction likely to cause death or injury |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |