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Facility profile

Apotex Inc.

Testing & analysis · Drug product manufacturing · Ontario L4C 5H2 · Canada

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed11 registered company locations
Potential fit

Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

AnalysisManufacture
Due diligence

Regulatory record at a glance

Use these records to guide qualification; they are not a facility score.

Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Official action indicated (OAI)

May 9, 2025 · The findings may warrant official FDA action.

Matched compliance actions
Warning Letter · Oct 2025

Within five years · review the action and follow-up.

Understand this record

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Shows

Registration status and a latest matched official action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

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Review the underlying findings, response, and subsequent follow-up before qualification.

Method and source details
View full inspection and compliance history11 inspection records

FDA inspection history

11 records, Aug 2010 – May 2025 · 5 NAI · 4 VAI · 2 OAI

DateClassProject areaCitationsFY
May 9, 2025OAIDrug Quality AssuranceYes2025
Mar 8, 2024NAIDrug Quality Assurance2024
Mar 24, 2023NAIBioresearch Monitoring2023
Sep 14, 2022VAIDrug Quality AssuranceYes2022
Jun 28, 2019NAIDrug Quality Assurance2019
Mar 22, 2019NAIBioresearch Monitoring2019
Apr 11, 2017VAIDrug Quality AssuranceYes2017
Mar 4, 2015NAIDrug Quality Assurance2015
Aug 30, 2013VAIDrug Quality AssuranceYes2013
Oct 26, 2012OAIDrug Quality Assurance2013
Aug 17, 2010VAIDrug Quality Assurance2010

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

Oct 31, 2025Warning Letter · CDER
Feb 21, 2013Warning Letter · CDER
Unclaimed profile

Service details not yet provided

Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

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