FDA Inspection 1062326 — Wu's Tech (Vietnam) Co., Ltd.

Wu's Tech (Vietnam) Co., Ltd. — FEI 3007963811

The FDA completed an inspection of Wu's Tech (Vietnam) Co., Ltd. on August 2, 2018 in Thu Dau Mot City. 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
August 2, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Thu Dau Mot City (Vietnam)

Citations

IDCFRDescription
53721 CFR 820.70(a)Production processes
73121 CFR 803.50(a)(1)Report of Death or Serious Injury