FDA 483 - Baxalta Belgium Manufacturing SA - May 20, 2019

An FDA inspection of Baxalta Belgium Manufacturing S.A. in Lessines, Belgium, a licensed biological manufacturer, revealed significant deficiencies across multiple areas. Observations included inadequate computer system validation and batch review processes, leading to product quality issues like endotoxin trends and visible particulates. The firm also failed to timely report biological product deviations and serious unexpected adverse events, and did not conduct adequate quality investigations for reported viral transmission and fungal infection events. Additionally, facility design was found to be inappropriate for cleaning and maintenance.