FDA Form 483 Issued to Jiangsu Hengrui Pharmaceuticals
THE BASICS In January 2024, the FDA issued a deeply concerning Form 483 to Jiangsu Hengrui Pharmaceuticals, a China-based manufacturer, during an inspection classified as Official Action Indicated (OAI). The inspection revealed eight primary observations, with six of these graded as Critical by Redica Systems’ Quality System Risk Models. When including secondary observations, nine out […]