FDA Inspection 902925 — EMG Technology Co., Ltd.
The FDA completed an inspection of EMG Technology Co., Ltd. on October 23, 2014 in Taichung City. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
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 |