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903515

Novocol Pharmaceutical of Canada, Inc. — FEI 3002807757

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 11, 2014
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Cambridge (Canada)

Facility

Other inspections at this facility

  • 1243223 (VAI Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1117454 (NAI Thu Jan 30 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1098218 (NAI Fri Jun 21 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1093310 (VAI Tue Jun 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1019963 (VAI Wed Jul 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
143521 CFR 211.42(c)(10)(v)Cleaning System
145121 CFR 211.113(b)Procedures for sterile drug products