FDA 483 - Resilience Boston Inc. - August 11, 2017

An FDA inspection of Sanofi Genzyme's drug substance manufacturing facility in Allston, MA, revealed significant deficiencies. Observations included inadequate cleaning validation for product contact parts, failures in the quality unit to ensure proper material testing and accurate reporting, and insufficient investigations into environmental microbial excursions. These issues indicate a lack of robust control over critical manufacturing processes and quality oversight.