FDA 483 - Nippon Kayaku Co., Ltd. - May 25, 2026

An FDA inspection of Nippon Kayaku Co., Ltd. in Takasaki, Gunma, Japan, an API and Finished Dosage Manufacturer, revealed deficiencies in supervisory oversight of laboratory electronic systems and data. The firm failed to reconcile official GMP documents from its ArcSuite Engineering system and did not conduct 100% review of audit trails and electronic data in its Lab Solutions chromatography software, raising concerns about data integrity and the absence of illegitimate testing.