FDA 483 - Nissui Corporation - December 15, 2023

Nissui Corporation in Tsukuba, Japan, was inspected by the FDA from December 11-15, 2023, revealing significant deficiencies. The firm failed to follow its written stability testing program, resulting in active pharmaceutical ingredient samples being stored under out-of-specification humidity conditions. Additionally, procedures for equipment cleaning and maintenance were found to be deficient, lacking proper schedules and scientific justification for not cleaning certain tanks.