FDA Inspection 915643 — Lepu Medical Technology (Beijing) Co., Ltd.
The FDA completed an inspection of Lepu Medical Technology (Beijing) Co., Ltd. on February 5, 2015 in Changping. 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
- February 5, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Changping (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |