FDA Inspection 986400 — Wuhan Gigaa Optronics Technology Co., Ltd.
The FDA completed an inspection of Wuhan Gigaa Optronics Technology Co., Ltd. on Jun 16, 2016 in Wuhan. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 16, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Wuhan (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |