FDA 483 - Hunan Warrant Chiral Pharmaceutical Co., Ltd. - November 14, 2025

An FDA inspection of Hunan Warrant Chiral Pharmaceutical Co., Ltd. in Changsha, China, an API manufacturer, identified significant deficiencies in their manufacturing and quality control systems. Observations included inadequate process validation, failure to establish proper yield ranges, and poorly qualified equipment and water systems. Additionally, the firm exhibited insufficient controls for computerized data and inadequate supplier qualification, indicating a lack of robust scientific justification and control over critical processes.