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# FDA 483 Cites Apotex Over Sterility, Data Integrity Failures
- URL: https://www.fdaweb.com/fda-483-cites-apotex-over-sterility-data-integrity-failures/
- Published: 2025-12-05T12:00:00.000Z
- Updated: 2026-09-14T15:28:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160334

FDA investigators issued a [24-page Form FDA-483](https://www.fda.gov/media/189935/download?ref=fdaweb.com) citing numerous manufacturing violations after a 12-day inspection in May of Apotex’s sterile drug facility in Richmond Hill, Ontario. The just-posted form identifies significant lapses in aseptic operations, cleaning, equipment maintenance, complaint investigations, and data integrity.

The 483 was the basis of a [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apotex-inc-714137-10312025?ref=fdaweb.com) issued to Apotex last month. In the letter, 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.

Additionally, the agency 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.