FDA 483 - Emergent Biosolutions LLC - August 16, 2023

An FDA inspection of Emergent Biosolutions LLC in Canton, MA, a licensed biological drug substance manufacturer, identified two significant issues. The firm failed to make records, specifically security camera footage used in deviation investigations for ACAM2000 bulk drug substance manufacturing, readily available for inspection. Additionally, aseptic process simulation studies did not accurately reflect routine aseptic manufacturing operations, particularly concerning the sterilization process for the ACAM2000 P10 viral process.