483
Henogen SRLHenogen SRL – FDA 483, Nov 22, 2024
Record Details
An FDA inspection of Henogen SRL, a viral vector manufacturer in Seneffe, Belgium, revealed a significant deficiency in control data related to the manufacturing of viral vectors. Specifically, the firm's batch records lacked adequate reconciliation of production yield and criteria for investigating excessively high or low yields. This indicates a potential lack of robust process control for critical manufacturing steps.
View Company Profile
ID · 2b8c2510-c4d6-4ff8-995d-f8e56407bf37
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.