FDA 483 - La Crosse Milling Co. - November 18, 2024

La Crosse Milling Co. in Cochrane, WI, an API manufacturer, received a Form 483 with five observations during an inspection from November 18-22, 2024. The observations primarily concern significant deficiencies in quality unit responsibilities, process and cleaning validation, label control, and batch production record documentation, indicating a lack of robust quality system controls.