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1167881

Niagara Pharmaceuticals Inc — FEI 3003093882

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 25, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Dundas (Canada)

Facility

Other inspections at this facility

  • 1117142 (OAI Fri Feb 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031416 (NAI Mon Sep 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 975165 (VAI Mon May 16 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 883362 (NAI Wed May 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 694739 (VAI Wed Sep 08 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
139521 CFR 211.103Actual vs. theoretical yields not determined
180321 CFR 211.84(b)Representative Samples Criteria
357021 CFR 211.100(a)Approval and review of procedures