FDA 483 - Kyowa Kirin Pharmaceutical Research, Inc. - March 02, 2020

An FDA inspection of Kyowa Kirin Pharmaceutical Research, Inc.'s biopharmaceutics analytical facility in La Jolla, California, from March 2-6, 2020, revealed a significant data integrity issue. The firm failed to report all precision and accuracy data from method validations associated with multiple studies. This indicates a concern regarding the completeness and reliability of their analytical data.