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

The FDA conducted an inspection of Shire Human Genetic Therapies, Inc. in Cambridge, MA, from September 3 to September 12, 2025. This inspection resulted in a Form FDA 483, citing several significant observations indicating potential deviations from Good Manufacturing Practices (GMP) and the Federal Food, Drug, and Cosmetic Act. Key issues observed included a failure to follow procedures designed to prevent microbiological contamination during drug substance manufacturing. Specific examples cited operators failing to maintain aseptic technique, such as touching non-sterile surfaces or not sanitizing hands and sleeves after handling biological materials in a biosafety cabinet. The FDA also noted inadequate airflow visualization studies for aseptic bottling operations, which were found to lack a critical aseptic connection step and were linked to a previous contamination event. Furthermore, the disinfectant efficacy study was deemed deficient for not evaluating all relevant surfaces, including operator gloves. The Quality Control unit's procedures were found lacking, as they did not include periodic evaluation of electronic audit trail data from testing equipment. Lastly, a critical manufacturing tank with a 'Cleaned' status was observed to have residue spots, indicating inadequate cleaning intervals. Shire Human Genetic Therapies, Inc. is expected to address these observations by implementing comprehensive corrective actions and preventive measures to ensure compliance with regulatory standards and prevent product contamination.