FDA 483 - Genzyme Corporation - March 18, 2026

Genzyme Corporation in Framingham, MA, a biologic drug substance manufacturer, received a Form 483 with six observations. The inspection revealed significant issues including the release of drug substance with particle contamination, inadequate investigations into manufacturing deviations and cleaning failures, and deficiencies in equipment re-qualification. Additionally, the firm failed to follow adequate production control procedures, maintain equipment appropriately, and establish proper laboratory control mechanisms.