FDA 483 - Shire Human Genetic Therapies, Inc. - March 23, 2022

An FDA inspection of Takeda's drug substance manufacturing facility in Lexington, MA, revealed four significant observations. These included inadequate manufacturing batch records for lanadelumab, a technician's failure to follow aseptic technique during sampling, insufficient control over a laminar flow clean bench system, and unqualified compressed gas utilities lacking critical testing.