Resilience US, Inc. – FDA 483, Oct 10, 2008

An FDA inspection of Genzyme Corporation in Allston, MA, revealed numerous deficiencies in drug manufacturing processes. Key issues included inadequate bioburden monitoring, poor control over batch production records, and insufficient documentation for manufacturing activities. The inspection also identified problems with aseptic processing qualification, equipment maintenance, and incomplete deviation files, indicating a broad lack of adherence to good manufacturing practices.