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

An FDA inspection of Emergent BioSolutions Canada Inc. in Winnipeg, MB, revealed significant deficiencies in their manufacturing processes. The observations primarily concern inadequate procedures to prevent microbial contamination, issues with aseptic processing using a Vanrx system, and insufficient laboratory controls for samples. These findings indicate potential risks to product sterility and quality.