> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Warns Apotex Canadian Manufacturing Site
- URL: https://www.fdaweb.com/fda-warns-apotex-canadian-manufacturing-site/
- Published: 2025-11-05T12:00:00.000Z
- Updated: 2026-09-14T15:25:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160163

FDA has issued a [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apotex-inc-714137-10312025?ref=fdaweb.com) to Apotex, citing significant GMP violations at the company’s Richmond Hill, Ontario, facility, including failures in sterility assurance, equipment maintenance, and quality investigations. The 10/31 letter follows an inspection conducted from 4/28 to 5/9 at the site, which manufactures sterile and oral drug products for the U.S. market. FDA said the company’s methods, facilities, and controls “do not conform” to GMPs, rendering its products “adulterated” under the Federal Food, Drug, and Cosmetic Act.

Inspectors found that Apotex failed to thoroughly investigate multiple production discrepancies involving leaks and container-closure integrity issues for several drug products distributed in the U.S. FDA said employees sometimes repeated leak tests until they passed, rather than investigating the cause of failures, leaving uncertainty about product sterility.

The agency also described widespread maintenance and contamination control issues in Apotex’s aseptic manufacturing areas. Inspectors observed deteriorated seals and gaskets, discolored gloves, tape used as makeshift repairs, and other insanitary conditions. In one case, a six-millimeter hole in a sterile glove was closed with a cable tie while production continued.

Apotex recalled several products after the inspection, including azelastine and ketorolac ophthalmic solutions and lacosamide oral solution, but FDA said those actions were “reactive and inadequate.” The agency criticized the company’s quality unit for lacking sufficient authority and oversight, saying its investigation and corrective action programs were ineffective and delayed.

The letter also cited failures to adequately monitor aseptic processing environments, to perform timely preventive maintenance, and to replace deteriorating equipment known to shed particles into drug products.

FDA ordered Apotex to conduct independent assessments of its investigation system, corrective and preventive action program, and change management procedures, along with a comprehensive risk evaluation of contamination hazards across its facilities.

Additionally, the agency warned that failure to correct the violations could result in import refusal of products manufactured at the site and potential withholding of new drug approvals listing Apotex as a manufacturer.