Spark Therapeutics, Inc. – FDA 483, Aug 25, 2017

Spark Therapeutics, Inc., a biologics drug substance manufacturer in Philadelphia, PA, was cited for significant quality system deficiencies. Observations included the untimely closure and review of deviations and investigations, a failure to consistently establish corrective actions for recurring human errors, and inadequacies in their CGMP training program, including a lack of periodic review of training records.