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852516

Purdue Pharma — FEI 3003287869

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 13, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pickering (Canada)

Facility

Other inspections at this facility

  • 1087591 (VAI Fri Apr 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1025638 (NAI Fri Aug 04 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 938743 (VAI Fri Jul 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 734736 (VAI Fri Jul 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
438321 CFR 211.198(b)(1)Written complaint record must include