FDA 483 - Ishihara Sangyo Kaisha, Ltd. - September 09, 2022

An FDA inspection of Ishihara Sangyo Kaisha, Ltd., an API manufacturer in Yokkaichi, Japan, revealed two significant quality system deficiencies. The firm failed to adequately document and investigate deviations from established procedures and did not consistently follow its own written procedures, including issues with deviation report closure and change control for cleaning validation.