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Apotex Inc.

Canada See location details
Last FDA Action: Jul 31, 2025

This drug manufacturing facility is registered with the FDA by Apotex Inc.. ProPublica was able to identify at least 191 generic drugs that have been manufactured at this facility.

Facility Inspection History

The FDA is responsible for inspecting drug manufacturing facilities for violations of good manufacturing practices, such as a lack of documented drug quality testing or contaminated equipment. Below is a timeline of FDA inspections and outcomes for this facility assembled by ProPublica.

Note: ProPublica does not provide medical advice. Stopping your medication, doctors warn, can be dangerous. Please consult your doctor first if you have concerns. Read more
10 Known Inspections

The inspections we were able to locate using available FDA data do not include inspections in advance of the release of a new drug product.

6 Inspections Found Issues

When issues are observed, inspectors usually file an FDA 483 form with citations. In more serious cases, the FDA can issue warning letters or even ban the import of drugs from the facility.

  • Jul 31, 2025
    Jul 31, 2025
    Inspection

    The FDA determined this facility was in an acceptable state.

    This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors.
  • Sep 23, 2022
    Sep 23, 2022
    Inspection

    The FDA determined this facility was in an acceptable state.

    This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors.
  • Jun 19, 2019
    Jun 19, 2019
    Inspection

    The FDA determined this facility was in an acceptable state.

    This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors.
  • May 10, 2018
    May 10, 2018
    Inspection

    The FDA determined this facility was in an acceptable state.

    This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors.
  • Jun 14, 2017
    Jun 14, 2017
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • May 11, 2015
    May 11, 2015
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    2 citations
    Late submission of 15-day report
    Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.
    Late submission of quarterly safety reports
    Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Aug 20, 2013
    Aug 20, 2013
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    7 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    Equipment for Environmental Control
    Equipment for adequate control over temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
    SOPs not followed / documented
    Written production and process control procedures are not followed in the execution of production and process control functions.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Aug 24, 2012
    Aug 24, 2012
    Inspection With Issues

    The FDA ruled the facility was in an “unacceptable state of compliance.”

    Inspectors found serious issues at the facility, and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.
    12 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    GMP Training Frequency
    GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.
    Sanitation--buildings not clean, free of infestation
    Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Mar 3, 2011
    Mar 3, 2011

    An import ban on the facility lifted some time after this date.

    The FDA doesn't publish a historic record of import alerts, but the last time we saw this facility on archived import bans lists was Mar 3, 2011.
  • Feb 11, 2011
    Feb 11, 2011
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Sep 30, 2009
    Sep 30, 2009
    Import Ban

    The FDA banned the import of medications from this facility.

    An import alert was issued for this facility, meaning the FDA had reason to believe products manufactured there violated FDA manufacturing standards and should not be allowed into the country.
  • Aug 14, 2009
    Aug 14, 2009
    Inspection With Issues

    The FDA ruled the facility was in an “unacceptable state of compliance.”

    Inspectors found serious issues at the facility, and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.

Drugs Manufactured Here

Below is a list of generic prescription drugs that we’ve been able to connect to this facility. Brand name and over-the-counter drugs, as well as labels we were unable to trace, are not included here.

Abiraterone Acetate

CompanyMajor Pharmaceuticals
Dosage
250mg
White to off-white oval tablet marked with A250 APO
NDC: 0904-6948-04

Abiraterone Acetate

CompanyApotex
Dosage
250mg
White to off-white oval tablet marked with A250 APO
NDC: 60505-4327-X

Adefovir Dipivoxil

CompanyApotex
Dosage
10mg
White to off white round tablet marked with APO A10
NDC: 60505-3947-3

Ambrisentan

CompanyApotex
Dosage
5mg
Pale pink square tablet, film coated marked with APO A5
NDC: 60505-4552-X

Ambrisentan

CompanyApotex
Dosage
10mg
Deep pink oval tablet, film coated marked with APO A10
NDC: 60505-4553-X

Balsalazide Disodium

CompanyBryant Ranch Prepack
Dosage
750mg
White capsule marked with APO B750
NDC: 72162-2095-2

Balsalazide Disodium

CompanyAvpak
Dosage
750mg
White capsule marked with APO B750
NDC: 50268-102-X

Balsalazide Disodium

CompanyApotex
Dosage
750mg
White capsule marked with APO B750
NDC: 60505-2575-X

Clopidogrel

CompanyNcs Healthcare Of Ky, Llc Dba Vangard Labs
Dosage
Clopidogrel Bisulfate
75mg
Pink round tablet, film coated marked with APO CL 75
NDC: 0615-8014-X

Clopidogrel

CompanyAmerican Health Packaging
Dosage
Clopidogrel Bisulfate
75mg
Pink round tablet, film coated marked with APO CL 75
NDC: 68084-536-X

Clopidogrel

CompanyAmerican Health Packaging
Dosage
Clopidogrel Bisulfate
300mg
Pink capsule-shaped tablet, film coated marked with APO CL300
NDC: 68084-752-X

Clopidogrel

CompanyAphena Pharma Solutions - Tennessee
Dosage
Clopidogrel Bisulfate
75mg
Pink round tablet, film coated marked with APO CL 75
NDC: 71610-527-60

Frequently Asked Questions

What Do the Inspection Outcomes Mean?
These are the possible FDA compliance outcomes we highlight:
  • Import alert. This is rare and means drugs from this facility were banned from coming into the U.S. Specifically we are including alerts relating to FDA manufacturing standards for drug products. The agency sometimes exempts certain drugs from import bans, ostensibly to prevent drug shortages.
  • Warning letter. This is a disciplinary tool the FDA uses to lay out significant violations of federal requirements. The company has an opportunity to respond and/or provide its plans to correct the issues. The agency might later issue a “close-out letter” to say it has confirmed that issues raised in a previous warning letter were fixed. But that doesn’t always happen.
  • Unacceptable state of compliance. This means inspectors found serious issues at the facility and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. The agency classifies this as “official action indicated.”
  • Some issues found, but no further FDA action. This is very common. It means the FDA found issues but determined the facility can correct them voluntarily. In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time. The agency classifies this as “voluntary action indicated.”
  • Inspector documented issues. Inspectors can file notes summarizing deficiencies observed during an inspection using a 483 form. In some cases, we’re unable to connect a Form 483 to an FDA inspection designation, but we show that an inspector filed this form, perhaps as part of an inspection that was not included in the public inspection dashboard.
  • Acceptable state. This is common and the best possible outcome for an inspection. This means the FDA took no compliance action and ProPublica found no issues documented by inspectors. That doesn’t always mean no issues turned up. Sometimes, inspectors address concerns with management on site that they believe do not need to be documented on a 483. The agency classifies this as “no action indicated.”
There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.

How Did ProPublica Connect This Information?
We have written an in-depth methodology, but in short, we connected several FDA databases:
  • The Structured Product Labeling database.
  • The National Drug Code Directory.
  • The Electronic Drug Registration and Listing System.
  • Data from the agency’s inspection dashboard.
  • A spreadsheet of facility addresses we sued the FDA for, which connected them to drug application numbers.
  • Form 483 documents we received from a Freedom of Information Act Request.
ProPublica described the app and the methodology used to build it to the FDA, which did not comment. The agency previously told ProPublica that it doesn’t reveal where drugs are made on inspection reports to protect what it deemed confidential commercial information.

How Do I Report Incorrect Information?
If you work for a manufacturer or otherwise see that information we are displaying may be incorrect, please email [email protected].