Home / Inspections / 1118319

1118319

Groupe Parima Inc. — FEI 3003773810

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 24, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Saint-Laurent (Canada)

Facility

Other inspections at this facility

  • 1215880 (VAI Fri Aug 25 2023 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
117721 CFR 211.63Equipment Design, Size and Location
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
1594221 CFR 111.105(i)QC- required operations equipment, instruments, controls
360321 CFR 211.160(b)Scientifically sound laboratory controls
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
438921 CFR 211.198(a)Procedures to be written and followed
440921 CFR 211.194(a)(4)Data secured in course of each test