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1216776

Delpharm Montreal Inc. — FEI 3002808099

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 1, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pointe-Claire (Canada)

Facility

Other inspections at this facility

  • 1118254 (NAI Fri Jan 17 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1034239 (VAI Fri Dec 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 989622 (NAI Fri Sep 02 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 866964 (NAI Fri Jan 31 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 748571 (VAI Fri Sep 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
180921 CFR 211.160(a)Following/documenting laboratory controls
208721 CFR 211.208Salvaging performed without evidence