Cangene BioPharma, LLC – FDA EIR, Jun 13, 2018

An FDA inspection of Cangene bioPharma, LLC., dba Emergent BioSolutions in Baltimore, MD, was conducted from June 4 to June 13, 2018. This Level I GMP inspection, part of the Team Biologics FY’18 work plan, covered plasma derivatives and vaccines, focusing on quality, production, facilities, equipment, and packaging/labeling systems. The inspection resulted in an eight-item FDA 483 observation list. Key violations included a lack of control in a manufacturing process, where product vials consistently broke during or after lyophilization, with reject rates up to 17%. The company had not implemented effective corrective actions over several years. Furthermore, deviations from production procedures were often not recorded; for instance, BioThrax product residue on vial exteriors was deemed an acceptable cosmetic defect without proper investigation, and frequent interventions on fill lines were undocumented. Aseptic procedures were also found deficient, with operators observed compromising sterile environments by holding hands over open vials and improperly sanitizing for monitoring. Additionally, media fills used dedicated pumps not representative of production, and lacked full vial accountability and scientific rationale for process times. Emergent BioSolutions' management committed to responding to the FDA within 15 business days.