902925
EMG Technology Co., Ltd. — FEI 3003803075
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 23, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Taichung City (Taiwan)
Citations
| ID | CFR | Description |
|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |