FDA 483 - Shire Human Genetic Therapies, Inc. - April 22, 2022

Shire Human Genetic Therapies, Inc. in Lexington, MA, an Active Pharmaceutical Ingredient Manufacturer, received a Form 483 for a critical lapse in its Quality unit's oversight. The firm failed to adequately assess the impact of chromatography systems that had not undergone routine calibration since 2014 on the analytical testing of Velaglucerase Alfa and Idursulfase drug substances and products. This indicates a significant control deficiency that could impact product quality.