FDA 483 - TOYO Pharmaceutical Co., Ltd. - June 16, 2023

TOYO Pharmaceutical Co., Ltd., a contract manufacturer in Osaka, Japan, was cited for significant deficiencies during an FDA inspection. Observations included failures to document deviations from production and process control procedures, such as out-of-specification results and overdue maintenance, and a lack of documented training for employees performing critical visual inspections of drug products. These issues indicate a breakdown in quality control and personnel qualification processes.