Emergent BioSolutions Canada Inc. – FDA EIR, Sep 13, 2019

An FDA surveillance inspection of Emergent BioSolutions Canada Inc. was conducted from September 5 to September 13, 2019. The inspection, carried out under Compliance Program 7356.002A for Sterile Drug Process Inspections, primarily focused on the firm's adherence to aseptic processing standards for sterile drug products. A significant violation, documented on an FDA 483 form, cited a failure to follow established procedures designed to prevent microbiological contamination, specifically regarding improper aseptic gowning technique (reference 21 CFR 211.113(b)). An operator was observed grasping the outside of sterile boot covers, which contradicted the firm's internal protocols. Additionally, during discussions with management, it was noted that the sterile gowning procedure lacked clear definition for all critical steps, such as the required wiping down of outer packaging for gowning materials. In response to the formal observation, Emergent BioSolutions promptly initiated a deviation report, retrained three involved operators, and committed to displaying laminated gowning instructions in the aseptic area to reinforce correct procedures. The firm also indicated it would address the procedural clarity for the discussed item and promised a written response to the FDA within 15 business days, outlining their comprehensive corrective actions.