Home / Inspections / 1162392

1162392

Spineology, Inc. — FEI 3003179719

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 15, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Compliance: Devices
Location
Saint Paul, MN (United States)

Facility

Other inspections at this facility

  • 1275322 (NAI Tue Jun 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1267116 (VAI Thu Apr 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1071565 (NAI Fri Oct 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1012390 (NAI Fri Mar 31 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 995031 (NAI Mon Dec 05 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
311721 CFR 820.70(i)Software validation for automated processes
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate