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Apotex Inc. — FDA Facility Profile

FEI 3002808376

Apotex Inc. is an FDA-registered facility (FEI 3002808376) located in Ontario M9W 6Y3, CA. Registered operations: ANALYSIS; MANUFACTURE. RegDataLab tracks 9 FDA inspections and 1 compliance action at this facility.

Facility Details

Location
Ontario M9W 6Y3 (CA)
Registration Expires
December 31, 2026
Operations
ANALYSIS; MANUFACTURE
Source
decrs

Recent inspections

  • 1249246 (NAI Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1230073 (NAI Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1114893 (NAI Fri Nov 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100432 (VAI Fri Jul 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1035875 (NAI Fri Dec 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 982370 (NAI Fri May 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 850692 (NAI Fri Sep 13 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 714923 (VAI Fri Feb 11 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 554921 (OAI Fri Dec 19 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • 799-6394684-1/11/1 (Tue Mar 24 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1309281-1/11/2 (Mon May 06 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-4455075-2/11/1 (Thu Mar 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-8642196-6/1/1 (Thu Aug 16 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-1767503-8/2/1 (Mon Sep 28 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-1767503-8/3/1 (Mon Sep 28 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-1767503-8/6/1 (Mon Sep 28 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-1767503-8/5/1 (Mon Sep 28 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-1767503-8/4/1 (Mon Sep 28 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-1767503-8/1/1 (Mon Sep 28 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources