FDA 483 - Genzyme Corporation - July 25, 2022

An FDA inspection of Genzyme Corporation in Framingham, MA, revealed significant deficiencies in the manufacture of Thyrogen bulk drug substance. Observations included inadequate controls over computerized systems, leading to unreviewed audit trails and omitted data, as well as poor facility maintenance with issues like rust, chipped floors, and leaks in manufacturing areas. These findings indicate a lack of control over critical manufacturing processes and environmental conditions.