FDA 483 - Shiono Finesse Ltd. - June 08, 2018

Shiono Finesse, Ltd. in Sakai, Fukui, an API manufacturer, was cited with eight observations during an FDA inspection. The observations highlight significant deficiencies in data integrity, equipment cleaning, maintenance programs, process validation, raw material sampling, change control, supplier qualification, and reserve sample management. These issues indicate a lack of robust quality control and adherence to good manufacturing practices.