FDA 483 - Emergent BioSolutions Canada Inc. - May 16, 2017

Cangene Corporation dba Emergent Biosolutions in Winnipeg, Canada, was cited for significant deficiencies during an FDA inspection. The observations include recurring HEPA filter failures impacting aseptic processing air quality, the presence of foreign materials like animal hair and glass in drug products, and inadequate post-marketing surveillance for adverse events. Additionally, the firm's process validation specifications for microbial data were found to be insufficient.