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783015

Primus Corporation dba Trinity Biotech — FEI 1931251

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 18, 2012
Fiscal Year
2012
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))
  • 1117396 (OAI Thu Feb 06 2020 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))

Recent compliance actions

Citations

IDCFRDescription
323021 CFR 820.70(i)Validation of changes to automated process software
323121 CFR 820.70(i)Documentation of software validation
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
912921 CFR 809.10(b)(5)(iv)Storage-instructions (no manipulation of reagent)