FDA 483 - REGI US INC - January 22, 2025

REGI US INC in West Caldwell, NJ, a drug manufacturer, received a Form FDA 483 with four observations during an inspection from January 14-22, 2025. The inspection revealed significant deficiencies in production and process controls, quality unit responsibilities, supplier qualification, and record keeping, particularly concerning sunscreen drug products. These issues indicate a lack of adherence to good manufacturing practices and proper quality oversight.