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Facility profile

Apotex Inc.

Testing-focused facility · Ontario M9L 2S8 · Canada

FDA recordFDA directory updated Jul 22, 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.

Analysis
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 22, 2026

Latest matched inspection
No action indicated (NAI)

Jul 31, 2025 · No conditions warranted FDA action in this inspection.

Matched compliance actions
Past action on file · 2013

More than five years old · review later records.

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Shows

Registration status and a latest matched no action indicated inspection.

Doesn’t show

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

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Method and source details
View full inspection and compliance history10 inspection records

FDA inspection history

10 records, Aug 2009 – Jul 2025 · 4 NAI · 4 VAI · 2 OAI

DateClassProject areaCitationsFY
Jul 31, 2025NAIBioresearch Monitoring2025
Sep 23, 2022NAIDrug Quality Assurance2022
Jun 19, 2019NAIDrug Quality Assurance2019
May 10, 2018NAIBioresearch Monitoring2018
Jun 14, 2017VAIDrug Quality Assurance2017
May 11, 2015VAIDrug Quality AssuranceYes2015
Aug 20, 2013VAIDrug Quality AssuranceYes2013
Aug 24, 2012OAIDrug Quality AssuranceYes2012
Feb 11, 2011VAIDrug Quality Assurance2011
Aug 14, 2009OAIDrug Quality Assurance2009

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

Matched compliance actions

Feb 21, 2013Warning Letter · CDER
Mar 29, 2010Warning Letter · CDER
Unclaimed profile

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