FDA EIR - Cangene Corporation - May 16, 2017

An FDA inspection of Cangene Corporation (operating as Emergent BioSolutions) in Winnipeg, Manitoba, was conducted from May 8-16, 2017. This Level II inspection, performed under Compliance Program 7345.848 for Biological Products (CBER), evaluated the firm's Quality, Production, and Laboratory Control Systems for hyperimmune and recombinant therapeutic proteins. The inspection identified significant manufacturing practice deficiencies, which led to the issuance of a four-item Form FDA-483, Inspectional Observations.

Key violations included recurring HEPA filter failures in aseptic processing air handling systems, indicating inadequate air quality control in critical manufacturing areas. Additionally, the firm's aseptic controls were found deficient in preventing foreign material contamination, with investigations revealing animal hair, metal, and glass particulates in products. A notable compliance issue was the failure to conduct required trend analyses for adverse events (AEs) for specific product lots, such as BAT® Lot 11300324, despite meeting the criteria outlined in the company's own procedures, including cases involving serious unexpected AEs and a reported death. The firm is required to address these observations with comprehensive corrective and preventive actions.