1279929

ENvue Medical (USA) Inc — FEI 3017081712

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 29, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Compliance: Devices
Location
Arlington Heights, IL (United States)

Citations

IDCFRDescription
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency
405921 CFR 820.22Quality Audits - defined intervals