FDA 483 - Livzon Group (Ningxia) Pharmaceutical Co., Ltd. - October 19, 2018

The FDA inspected Livzon Group (Ningxia) Pharmaceutical Co., Ltd., an API and intermediate manufacturer, and found significant deficiencies across multiple areas. These included inadequate equipment cleaning, poor warehousing controls, facilities in disrepair, and insufficient labeling procedures. The inspection also revealed issues with stability studies, inventory records, environmental monitoring, OOS investigations, laboratory controls, batch record documentation, and shipping records.