Emergent BioSolutions Canada Inc. – FDA EIR, May 16, 2017

An FDA inspection of Cangene Corporation, operating as Emergent BioSolutions, took place from May 8 to May 16, 2017, at their Winnipeg, Manitoba facility. This inspection, conducted under the Office of Biologics Program Operations (CBER) Compliance Program 7345.848 for Biological Products, focused on the Quality, Production, and Laboratory Control Systems for the firm's manufactured hyperimmune products and recombinant therapeutic proteins. The inspection revealed several critical violations. Firstly, aseptic processing areas demonstrated deficiencies in air handling systems, evidenced by recurring HEPA filter failures across three consecutive certifications. These failures involved exceeding velocity action limits and failing filter integrity tests, compromising air quality. Secondly, aseptic controls were inadequate in preventing foreign materials, with investigations identifying animal hair, metal, and glass particulates in products during visual inspections. Thirdly, the company failed to consistently conduct required trend analyses for adverse events linked to specific product lots, as stipulated by their PostMarketing Surveillance SOP, particularly for the Botulism Antitoxin Heptavalent (BAT®) product. Lastly, specifications for process validations were deemed inadequate, showing microbial data inconsistent with established bioburden and endotoxin limits. At the conclusion of the inspection, a four-item Form FDA 483, detailing these "Objectionable Conditions," was issued to the Senior Director of Quality Assurance. The company acknowledged the observations and had initiated corrective and preventive actions, particularly for the HEPA filter issues, to rectify the identified good manufacturing practice deficiencies and ensure product safety and efficacy.