483
Nissui CorporationNissui Corporation – FDA 483, Dec 15, 2023
Record Details
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.
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ID · 34258a92-1db6-44ed-afa2-b4df7939b094
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