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 of 29 were deemed Critical, painting a troubling picture of the company’s quality control practices.
The FDA’s observations highlighted a range of serious issues, including microbial contamination, inadequate control of sterile products, lack of facility controls, and insufficient procedures. Perhaps most alarmingly, the FDA reported that Jiangsu Hengrui Pharmaceuticals was observed withholding and destroying documentation during the inspection, which contained records of these violations. This obstruction impeded the FDA’s ability to conduct an effective review and constitutes a serious violation in itself.
THE BUZZ
Redica Systems posted a full analysis of this 483 and its implications in a LinkedIn post here. A PDF of the 483 is available for purchase here.
