FDA issues warning letter to Apotex Inc for major CGMP violations

11th December 2025

FDA issues warning letter to Apotex Inc for major CGMP violations

Summary: On 31st October 2025, the FDA issued a warning letter to Apotex Inc. following an inspection of its Richmond Hill, Ontario, Canada manufacturing site conducted from April to May 2025. The agency found that Apotex’s manufacturing controls failed to comply with Current Good Manufacturing Practice (CGMP) regulations, leading to adulterated drug products for the U.S. market. Key violations included repeated failure to properly investigate out-of-specification leak test results, with personnel retesting until passing rather than identifying root causes; poor sterility assurance procedures, including damaged equipment, deteriorated seals and contamination risks; and inadequate investigation and corrective action for container-closure integrity issues. In response, Apotex temporarily suspended production and distribution of certain sterile solutions and spray products and initiated recalls, but the FDA deemed its corrective actions insufficient. The agency has required comprehensive corrective plans to address quality system deficiencies.

Link: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apotex-inc-714137-10312025

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