FDA EIR - Cangene BioPharma, LLC - February 16, 2019

An FDA inspection was conducted at Cangene BioPharma LLC. dba Emergent BioSolutions in Rockville, MD, from February 11-16, 2019. This abbreviated Level II GMP inspection focused on the manufacturing of ACAM2000 vaccine, adhering to Compliance Program 7345.848 for Biological Drug Products. The inspection identified three main objectionable conditions, leading to the issuance of an FDA 483 form. Firstly, procedures to prevent microbiological contamination of sterile drug products were deemed inadequate. Issues included insufficient operator gowning during isolator cleaning, leading to hair contamination, and an improper "clean hold time" practice where isolator doors remained open before sterilization. Furthermore, aseptic process simulations lacked complete documentation for rejected vials and comprehensive vial accountability, and sterilization validation for scale weights inside isolators was not confirmed with biological indicators. Secondly, the company failed to justify deviations from production and process control procedures. This was evident in the handling of ACAM2000 lots with a "yellow cake" appearance defect, where affected vials were not placed on stability. Additionally, investigations into the source of particulates found during visual inspections, including media fills, were not routinely performed unless a high defect threshold was met. Lastly, Emergent BioSolutions had not implemented any investigations or corrective actions despite persistent low-level mold recoveries, such as Aspergillus and Penicillium species, in the manufacturing facility since 2017. Management committed to responding to the FDA within 15 business days, addressing these critical observations and outlining required corrective actions.