Janssen Biologics B.V. – FDA 483, Sep 21, 2012

Janssen Biologics B.V. in Leiden, The Netherlands, was cited for significant issues during an FDA inspection related to its biological bulk drug substance manufacturing. The inspection revealed failures in preventing microbial and endotoxin contamination during production, with numerous out-of-specification events reported. Additionally, the Quality Unit failed to conduct complete investigations and implement timely corrective and preventive actions for these contamination issues.