FDA 483 - Henogen SRL - November 22, 2024

Henogen SRL, a viral vector manufacturer in Seneffe, Belgium, was inspected by the FDA, revealing a significant issue with the control data for manufacturing viral vectors. Specifically, the firm's batch records lacked adequate reconciliation of production yield and criteria for investigating yield deviations. This indicates a moderate severity issue related to quality control and data integrity in their manufacturing processes.