Ningxia Qiyuan Pharmaceutical Co., Ltd. – FDA 483, Sep 12, 2023

An FDA inspection of Ningxia Qiyuan Pharmaceutical Co., Ltd. in Yinchuan, China, an API manufacturer, revealed significant deficiencies in their equipment cleaning procedures. The firm's cleaning protocols lacked sufficient detail, failing to establish critical parameters like maximum time between processing and cleaning, clean hold times, and methods to prevent contamination. These issues raise concerns about the reproducibility and effectiveness of their cleaning processes for API manufacturing.