FDA Inspection 987864 — E-Teng Technology, Inc.
The FDA completed an inspection of E-Teng Technology, Inc. on Jul 14, 2016 in New Taipei City. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 14, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- New Taipei City (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |