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1117396

Primus Corporation dba Trinity Biotech — FEI 1931251

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 6, 2020
Fiscal Year
2020
Product Type
Devices
Project Area
Compliance: Devices
Location
Kansas City, MO (United States)

Facility

Other inspections at this facility

  • 1180790 (NAI Mon Sep 26 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1154252 (NAI Fri Sep 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1064644 (NAI Thu Sep 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 912071 (NAI Fri Jan 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 783015 (VAI Fri May 18 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
310421 CFR 820.30(j)Design history file
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
420821 CFR 806.20(a)Records not kept