FDA Inspection 955604 — XuZhou Kernel Medical Instrument Equipment Co. Ltd
The FDA completed an inspection of XuZhou Kernel Medical Instrument Equipment Co. Ltd on Nov 12, 2015 in Xuzhou. 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 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 |