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1034239

Delpharm Montreal Inc. — FEI 3002808099

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 8, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pointe-Claire (Canada)

Facility

Other inspections at this facility

  • 1216776 (VAI Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118254 (NAI Fri Jan 17 2020 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
111121 CFR 211.25(a)Training , Education , Experience overall
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
122721 CFR 211.67(c)Cleaning/maintenance records not kept
435321 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs