FDA Inspection 1052173 — Wondfo USA Co Ltd
The FDA completed an inspection of Wondfo USA Co Ltd on May 11, 2018 in Bolingbrook, IL. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 11, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Bolingbrook, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 3838 | 21 CFR 820.40(a) | Document review procedures, designated individual |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |