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