FDA Inspection 955604 — XuZhou Kernel Medical Instrument Equipment Co. Ltd
The FDA completed an inspection of XuZhou Kernel Medical Instrument Equipment Co. Ltd on November 12, 2015 in Xuzhou. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 12, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Xuzhou (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |