FDA 483 - Shire Human Genetic Therapies Inc - September 12, 2025

An FDA inspection of Shire Human Genetic Therapies, Inc. in Cambridge, MA, revealed multiple deficiencies in aseptic manufacturing and quality control. The firm failed to follow procedures to prevent microbiological contamination, had inadequate airflow visualization studies, and lacked comprehensive disinfectant efficacy testing. Additionally, the quality control unit did not periodically evaluate electronic audit trail data, and equipment was not cleaned properly, indicating significant risks to drug substance quality and purity.