FDA 483 - Rohto Pharmaceutical Co., Ltd. (Ueno Plant) - March 08, 2023

Rohto Pharmaceutical Co., Ltd (Ueno Plant) received a Form 483 following an inspection of its sterile drug manufacturing facility in Iga Mie, Japan. The observations primarily highlight significant deficiencies in aseptic processing controls, including inadequate procedures for preventing microbiological contamination, insufficient production and process controls, and failures in complaint handling and laboratory testing. These issues indicate a lack of robust quality systems necessary to ensure the sterility and quality of drug products distributed to the U.S. market.