Genzyme Corporation – FDA 483, Sep 4, 2020

Genzyme Corporation, a drug substance manufacturer in Framingham, MA, was cited for two observations during an FDA inspection. The inspection revealed inadequate maintenance of facilities and equipment, including issues with sterilization equipment, air filters, and diffusers. Additionally, the QC Microbiology Laboratory had uncertified equipment and failed to conduct logbook reviews according to established procedures.