FDA Inspection 1108576 — Hubei Weikang Protective Products Co., Ltd.
The FDA completed an inspection of Hubei Weikang Protective Products Co., Ltd. on October 30, 2019 in Xiantao. 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
- October 30, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Xiantao (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |