FDA EIR - Genzyme Corporation - September 04, 2020

An FDA inspection of Genzyme Corporation's Framingham, Massachusetts facility took place from August 26 to September 4, 2020, focusing on drug substance manufacturing. The inspection, conducted under Good Manufacturing Practices (GMP) regulations, identified several observations requiring corrective actions. Primary issues included inadequate sealing of diffuser screens in a mechanical room, posing potential contamination risks. Management responded by tightening all fasteners. A second significant observation concerned the Quality Control Microbiology Laboratory, where an analytical balance (Sartorius F-16499) used for critical testing was not adequately certified according to USP 41 standards, and several logbooks exceeded the procedural timeframe for secondary review. Genzyme certified the balance immediately and addressed the logbook issue by opening a deviation, identifying an inadequate procedure as the root cause, implementing a new process, and planning a transition to a Laboratory Information Management System (LIMS) for improved control. Additionally, the FDA noted that resolution of elevated endotoxin levels from a pretreatment system was suboptimal, prompting a change control for routine testing. Inspectors also highlighted overdue quality agreement reviews and suggested improving communication with technicians regarding environmental monitoring excursions to enhance aseptic technique awareness. While immediate corrective actions were taken for identified deficiencies, the inspection underscored the need for continuous adherence to robust quality systems and documentation practices.