FDA 483 - Ningxia Qiyuan Pharmaceutical Co., Ltd. - June 25, 2019

Ningxia Qiyuan Pharmaceutical Co., Ltd., an API manufacturer in Yinchuan, China, was cited for six observations during a June 2019 FDA inspection. Key issues included repeat observations of non-contemporaneous record-keeping, inadequate quality unit responsibilities, insufficient contamination precautions, and poorly detailed cleaning and laboratory procedures. Additionally, the facility's buildings were not properly maintained, with water leaks observed in warehouses.