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1305244

Caerus Corp dba OrthoCor Medical — FEI 3008216220

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 27, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Blaine, MN (United States)

Facility

Other inspections at this facility

  • 1191173 (NAI Tue Nov 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1088096 (NAI Wed Apr 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1072151 (NAI Wed Oct 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 946141 (NAI Wed Sep 09 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 735900 (NAI Fri Jul 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
23087ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
23255ISO 13485:2016 Clause 8.5.2Corrective action not taken