FDA Inspection 1180747 — Wu's Tech (Vietnam) Co., Ltd.
The FDA completed an inspection of Wu's Tech (Vietnam) Co., Ltd. on September 22, 2022 in Thu Dau Mot City. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 22, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Thu Dau Mot City (Vietnam)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |