FDA 483 - Takeda Pharmaceuticals USA, Inc. - September 09, 2016

An FDA inspection of Takeda Development Center Americas, Inc. revealed significant deficiencies in their pharmacovigilance system, primarily concerning the timely reporting of adverse drug experiences. The firm failed to report serious and unexpected adverse drug events and their follow-up information within the required 15 calendar days, with delays extending up to 2.5 years. Additionally, the inspection found issues with the review of adverse drug experience information, the reliability of electronic records, and the effectiveness of corrective and preventative actions and data exchange systems.