FDA 483 - Ningxia Qiyuan Pharmaceutical Co., Ltd. - June 25, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · f94bea60-ccfe-4962-946b-dd09d24728ae