FDA Inspection 906051 — Shanghai MediWorks Precision Instruments Co., Ltd.
The FDA completed an inspection of Shanghai MediWorks Precision Instruments Co., Ltd. on November 20, 2014 in Shanghai. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 20, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Shanghai (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |