FDA 483 - Harbin Jixianglong Biotech Co., Ltd. - November 06, 2025

Harbin Jixianglong Biotech Co., Ltd. in Harbin, China, an API manufacturer, was cited for significant deficiencies during an FDA inspection. The observations highlight severe issues across quality control, manufacturing processes, data integrity, and documentation, indicating a lack of robust quality systems. These include distributing API without validation, inadequate laboratory controls, poor equipment cleaning, and insufficient computer system controls.