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1269710

Apotex Inc. — FEI 3001617666

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 9, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Richmond Hill (Canada)

Facility

Other inspections at this facility

  • 1231036 (NAI Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1203170 (NAI Fri Mar 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1179507 (VAI Wed Sep 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1098988 (NAI Fri Jun 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1086265 (NAI Fri Mar 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
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
180921 CFR 211.160(a)Following/documenting laboratory controls
202721 CFR 211.192Investigations of discrepancies, failures
241921 CFR 211.198(a)Complaint Handling Procedure
358321 CFR 211.110(a)Written in-process control procedures