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1010679

Apotex Inc. — FEI 3001617666

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 11, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Richmond Hill (Canada)

Facility

Other inspections at this facility

  • 1269710 (OAI Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))

Recent compliance actions

Citations

IDCFRDescription
145221 CFR 211.113(b)Validation lacking for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures