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1215880

Groupe Parima Inc. — FEI 3003773810

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 25, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Saint-Laurent (Canada)

Facility

Other inspections at this facility

  • 1118319 (VAI Fri Jan 24 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1049889 (VAI Fri Apr 27 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 964127 (NAI Fri Jan 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 848381 (NAI Fri Aug 30 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 746755 (VAI Tue Sep 13 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
122721 CFR 211.67(c)Cleaning/maintenance records not kept
126321 CFR 211.68(b)Computer control of master formula records
135821 CFR 211.100(b)SOPs not followed / documented
154021 CFR 211.125(a)Strict control not exercised over labeling issued
180921 CFR 211.160(a)Following/documenting laboratory controls