FDA 483 - Genzyme Corporation - July 09, 2024

Genzyme Corporation in Framingham, MA, a human biologic drug substance manufacturer, was inspected by the FDA and received a Form 483 with six observations. The inspection revealed significant issues including inadequate investigation of deviations, inability to demonstrate reproducible manufacturing processes, poorly designed equipment, and a quality unit failing to ensure CGMP compliance. Additionally, the firm failed to follow production procedures and maintain clean facilities and equipment, indicating systemic control deficiencies.