FDA EIR - Bora Pharmaceuticals Injectables Inc - April 16, 2021

An FDA inspection of Cangene bioPharma LLC, dba Emergent BioSolutions, located in Baltimore, MD, was conducted from April 12-16, 2021. This comprehensive review, performed under Compliance Program 7356.002M for sterile drug product inspections, was a mission-critical Emergency Use Authorization (EUA) assignment focusing on specific Investigational New Drug operations. The inspection encompassed the company's Quality, Facilities and Equipment, Production, Packaging and Labeling, and Laboratory Control Systems.

Upon conclusion, a four-item FDA 483 "Inspectional Observations" was issued to the company. Main violations included the firm's failure to adequately justify the release of sterile drug product where container closure integrity was questionable, and the absence of established specifications for incoming vials visually inspected by a third-party vendor. Furthermore, inspectors observed aseptic techniques that did not conform to standard operating procedures or smoke study simulations. Lastly, individual logs for visual inspection equipment were lacking, preventing proper tracking of usage by employees or for specific batches. Emergent BioSolutions' management committed to submitting a written response to the agency addressing these observations within 15 business days.