FDA EIR - Genzyme Corporation - June 25, 2022

Genzyme Corporation, a manufacturer of therapeutic bulk drug substances for sterile injectable products located in Framingham, MA, was subject to an FDA inspection from July 18 to July 25, 2022. This surveillance inspection, conducted under Compliance Program 7356.002M and ICH Q7A guidelines for Active Pharmaceutical Ingredients, primarily assessed the company's quality, production, facilities, equipment, and laboratory systems supporting the commercial manufacture of Thyrogen.

Upon conclusion, the FDA issued a 2-item Form FDA 483, detailing significant observations. The first deficiency identified was a failure to exercise sufficient controls over computerized systems and adequately prevent data omission. Specifically, the firm's filter integrity testers used for critical process steps lacked proper audit trail review, and not all electronic test results, including failed and canceled tests, were integrated into manufacturing records. For example, several failed and cancelled filter integrity tests for Thyrogen bulk drug substance production were not documented as required. The second observation noted a failure to properly maintain buildings and facilities essential for bulk drug substance manufacturing. Genzyme Corporation is required to submit a comprehensive written response addressing these inspectional findings and outlining corrective actions.