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Apotex Inc.'s Toronto-area drug manufacturing facility was cited for significant Current Good Manufacturing Practice (CGMP) violations involving finished pharmaceutical products, specifically solutions and spray drug products distributed to the U.S. market. The company failed to adequately investigate critical equipment failures and container-closure integrity issues, with production personnel repeatedly performing leak tests until obtaining passing results rather than investigating root causes—a practice that continued for over a year between September 2023 and April 2025 without proper assessment of impact on other affected batches. These manufacturing control deficiencies rendered the firm's drug products adulterated under federal law.