FDA Inspection 1101816 — Ningbo Luke Medical Devices Co., Ltd.
The FDA completed an inspection of Ningbo Luke Medical Devices Co., Ltd. on September 5, 2019 in Yuyao City. 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
- September 5, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Yuyao City (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |