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Apotex Inc. — FDA Facility Profile

FEI 3002906944

Apotex Inc. is an FDA-registered facility (FEI 3002906944) located in Ontario M9L 1T9, CA. Registered operations: ANALYSIS; MANUFACTURE. RegDataLab tracks 10 or more FDA inspections and 1 compliance action at this facility.

Facility Details

Location
Ontario M9L 1T9 (CA)
Registration Expires
December 31, 2026
Operations
ANALYSIS; MANUFACTURE
Source
decrs

Recent inspections

  • 1269753 (NAI Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1187415 (NAI Fri Sep 23 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1096465 (NAI Wed Jun 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1055197 (NAI Thu May 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014399 (VAI Wed Jun 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 927965 (VAI Mon May 11 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 852610 (VAI Tue Aug 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 799252 (OAI Fri Aug 24 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 712527 (VAI Fri Feb 11 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 610738 (OAI Fri Aug 14 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • SCS-3885306-2/10002/1 (Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1232019-2/20003/1 (Tue Dec 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5212840-5/10003/1 (Mon Oct 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5212840-5/20003/1 (Mon Oct 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-5679307-6/21/1 (Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-0832331-5/11/1 (Tue Jun 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-9646009-3/21/1 (Tue Feb 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-8303892-8/11/2 (Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-8303892-8/11/1 (Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-4072402-1/21/1 (Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources