Henogen SRLNovember 22, 2024

FDA 483 - Henogen SRL - November 22, 2024

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Record Details

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.

Company: Henogen SRL
Inspection Date: November 22, 2024
Product Type: Biologics
Office: Division of Blood Components and Devices
People: Scott T. Ballard
Priscilla M. Pastrana (investigator)

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ID · 53cee9cf-582a-4b5b-9e20-8b6807483f93