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1289886

Jubilant HollisterStier General Partnership — FEI 3001623073

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 3, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Kirkland (Canada)

Facility

Other inspections at this facility

  • 1242347 (OAI Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1181741 (NAI Fri Oct 07 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1054645 (VAI Fri Jun 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 953135 (VAI Thu Dec 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 850579 (VAI Thu Sep 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
136121 CFR 211.100(a)Absence of Written Procedures
143521 CFR 211.42(c)(10)(v)Cleaning System
143621 CFR 211.42(c)(10)(vi)Equipment to control conditions
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls