FDA 483 - Genzyme Flanders - November 07, 2025

The FDA inspected Genome Flanders in Geel, Belgium, a biological drug substance manufacturer, and found significant deficiencies across four observations. Key issues include inadequate deviation management, poor facility and equipment maintenance leading to leaks, compromised electronic testing data integrity, and insufficient laboratory control procedures for microbiological monitoring. These findings indicate a serious lack of quality oversight and control in critical manufacturing and testing processes.