1176368

3DPX Medical — FEI 3017567754

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 28, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Compliance: Devices
Location
Chicago, IL (United States)

Citations

IDCFRDescription
1472221 CFR 820.40Procedures not adequately established or maintained
327021 CFR 820.80(c)Documentation
54621 CFR 820.75(a)Lack of or inadequate process validation