FDA 483 - Emergent BioSolutions Canada Inc. - May 10, 2022

An FDA inspection of Emergent BioSolutions Canada Inc. in Winnipeg, MB, from May 2-10, 2022, revealed significant deficiencies in sterile drug product manufacturing. Observations included inadequate procedures to prevent microbial contamination, issues with the cleaning, validation, and environmental monitoring of an automated filling isolator, and insufficient laboratory controls for microbial samples. These findings suggest a high risk of product contamination and a need for comprehensive corrective actions in aseptic processing and quality control.