FDA 483 - Spark Therapeutics, Inc. - March 04, 2022

Spark Therapeutics Inc. in Philadelphia, Pennsylvania, a drug substance manufacturer, received a Form 483 citing significant issues across its manufacturing and quality systems. Observations included repeated process deviations with insufficient stability data, inadequate Out of Specification investigations and change control for analytical methods, and a critical lack of quality oversight for contract manufacturers of its Luxturna product. These findings indicate deficiencies in process control, quality unit responsibilities, and vendor management.