FDA 483 - Nippon Rika Co., Ltd. - July 04, 2025

An FDA inspection of Nippon Rika Co., Ltd. in Ashikaga, Japan, an API manufacturer, revealed seven significant observations. The firm was cited for deficiencies in stability testing method verification, inadequate control of quality control samples, and insufficient review of electronic laboratory data. Additionally, issues included poor computer system controls, an inadequate process validation program, incorrect batch record yield calculations, and a failure to thoroughly investigate discrepancies and implement preventive actions.