FDA Inspection 706893 — Abbott Diagnostics (Shanghai) Co., Ltd.
The FDA completed an inspection of Abbott Diagnostics (Shanghai) Co., Ltd. on December 2, 2010 in Shanghai. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 2, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Shanghai (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |