FDA 483 - Emergent BioSolutions Canada Inc. - June 12, 2012

Cangene Corporation in Winnipeg, MB, Canada, was inspected by the FDA, revealing significant deficiencies in manufacturing process investigations, quality control, document management, and adherence to written procedures. The inspection highlighted issues such as inadequate investigations into process interruptions, insufficient reject rate establishment for defects, and uncontrolled critical documents, indicating a lack of robust quality systems. These findings suggest potential risks to product quality and compliance with regulatory standards.