Rohto Pharmaceutical Co., Ltd. (Ueno Plant) – FDA 483, Aug 25, 2026

An FDA inspection of Rohto Pharmaceutical Co., Ltd.'s Ueno Plant in Iga, Japan, a sterile drug manufacturing facility, revealed significant deficiencies in aseptic processing, environmental controls, and data integrity. Observations included inadequate validation of aseptic processes, insufficient cleaning and disinfection procedures, and failures in environmental monitoring. Additionally, the firm lacked proper qualification for a visual inspection machine, had deficient raw material testing for objectionable organisms, and exhibited poor controls over computer systems, raising concerns about data integrity.