FDA 483 - Cangene bioPharma, LLC., dba Emergent BioSolutions

An FDA inspection of Cangene bioPharma, LLC., dba Emergent BioSolutions in Rockville, MD, a drug (vaccine) manufacturer, revealed significant deficiencies in sterile manufacturing procedures, including inadequate gowning, isolator cleaning, and aseptic process simulation documentation. The inspection also cited unjustified deviations from production procedures, such as issues with visual inspection of ACAM2000 vials, and a failure to investigate persistent mold contamination within the facility. These observations indicate a moderate to severe level of non-compliance impacting product quality and safety.