FDA 483 - Emergent BioSolutions Canada Inc. - August 27, 2025

An FDA inspection of Emergent BioSolutions Canada Inc. in Winnipeg, MB, from August 19-27, 2025, revealed significant deficiencies in procedures designed to prevent microbiological contamination of sterile drug products. The firm lacked adequate operator monitoring, sterile gowning, cleaning protocols, and environmental controls in critical manufacturing areas, increasing the risk of product contamination.