FDA EIR - Cangene BioPharma, LLC - May 10, 2019

An FDA Good Manufacturing Practice (GMP) surveillance inspection of Cangene bioPharma, LLC. dba Emergent BioSolutions in Baltimore, MD, was conducted from May 7-10, 2019. The inspection, guided by 21 CFR Part 210 & 211 and Compliance Program 7356.002A for sterile drug products, covered quality, material, facilities and equipment, production, labeling, and laboratory systems. The company operates as a contract manufacturer for sterile, injectable drug products. Notably, no formal FDA Form 483 (Inspectional Observations) was issued during this inspection, indicating a satisfactory state of compliance. All eight observations from a previous June 2018 inspection, which cited concerns about manufacturing process control, deviation recording, contamination prevention, facility space, performance qualification, mold investigations, building maintenance, and timely record provision, were confirmed as addressed by the firm. While no formal violations were identified during this inspection, three discussion items were raised with management as areas for recommended action: ensuring all equipment is consistently labeled with current calibration and maintenance dates, establishing formal procedures to address broken security ties on bins containing unlabeled, filled vials, and implementing a procedure to prevent untimely material entry into the material management system. These points serve as guidance for continuous operational enhancement.