FDA 483 - Apotex Inc. - May 09, 2025

Apotex Inc. received a Form 483 citing significant deficiencies across its manufacturing operations, particularly concerning aseptic processing and quality control. Issues included inadequate investigations into product leaks and out-of-specification results, poor equipment maintenance leading to contamination risks, and insufficient procedures for visual inspection and container closure integrity testing. The report also highlighted deficiencies in aseptic process validation, data integrity controls for computerized systems, and the handling of market complaints.