FDA Inspection 1015062 — Well-Life Healthcare Limited

Well-Life Healthcare Limited — FEI 3006850006

The FDA completed an inspection of Well-Life Healthcare Limited on June 1, 2017 in New Taipei City. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 1, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
New Taipei City (Taiwan)

Citations

IDCFRDescription
260421 CFR 820.30(e)Design review - Lack of or inadequate procedures