FDA 483 - Henogen SRL - November 22, 2024

An FDA inspection of Henogen SRL, a viral vector manufacturer in Seneffe, Belgium, took place from November 14 to November 22, 2024. The inspection resulted in a Form FDA 483, identifying significant observations related to manufacturing control data and record-keeping practices. Specifically, the FDA noted a lack of adequate control data in viral vector manufacturing. Batch records for downstream processing did not include a reconciliation of production yield. Additionally, while certain operational records included yield calculations, there were no defined criteria for investigating batches with unusually high or low yields. This deficiency was particularly concerning as five batches of the viral vector had been manufactured and released without such exception criteria established.

Issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, these observations require Henogen SRL to implement corrective actions. The company is expected to address these findings by improving process control and data integrity, establishing comprehensive yield reconciliation methods, and defining clear investigation criteria for yield variations to ensure product quality and adherence to regulatory standards.