FDA 483 - Genzyme Flanders - November 07, 2025

Genome Flanders, a biological drug substance manufacturer in Geel, Belgium, was cited for significant deficiencies across its quality system. Observations included inadequate deviation management, poorly maintained facilities and equipment leading to leaks, compromised electronic testing data integrity, and unestablished laboratory control procedures for microbiological monitoring. These issues indicate a systemic failure to ensure product quality and compliance with good manufacturing practices.