FDA Inspection 1101816 — Ningbo Luke Medical Devices Co., Ltd.
The FDA completed an inspection of Ningbo Luke Medical Devices Co., Ltd. on Sep 5, 2019 in Yuyao City. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 5, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |