FDA 483 - Emergent BioSolutions Canada Inc. - September 13, 2109

An FDA inspection of Emergent BioSolutions Canada Inc. in Winnipeg, MB, Canada, a contract manufacturer of sterile human drugs, revealed a critical lapse in contamination prevention. Specifically, procedures designed to prevent microbiological contamination of sterile drug products were not followed during equipment setup. This indicates a potential risk to product sterility.