FDA 483 - Shire Human Genetic Therapies, Inc. - December 18, 2025

Between December 4 and December 18, 2025, the FDA inspected Shire Human Genetic Therapies, Inc., a drug substance manufacturer located in Lexington, Massachusetts. The inspection identified several significant quality and safety violations. Primary issues included the failure to maintain manufacturing equipment, specifically centrifuges that exhibited physical damage and unidentified residues. These equipment deficiencies were linked to previous microbial contamination events. Additionally, the firm failed to ensure that laboratory testing methods remained reliable, noting high rates of invalid assays and out-of-specification results for drug substances. Investigators also found that airflow visualization studies for sterile filling areas were inadequate, as they did not demonstrate that air moved correctly to prevent contamination. Furthermore, the company released drug batches without following internal approval procedures and failed to maintain proper records for samples used in staff training. These observations were issued under the regulatory authority of the Federal Food, Drug, and Cosmetic Act. While the report does not constitute a final agency determination, the company is required to respond by either disputing the findings or submitting a comprehensive plan for corrective actions to the FDA’s New England District Office.