Nanjing Hanxin Quality Unit Not Effective, FDA Says

FDA says its review of records submitted to it in response to an 11/18/2025 request determined that the Nanjing Hanxin Pharmaceutical Technology Co. in Nanjing Shi, Jiangsu Sheng, China, had a significant deviation from current good manufacturing practice (CGMP) requirements for active pharmaceutical ingredients (APIs). An 11/3 Warning Letter says the specific deviation was the failure of the firm’s quality unit to exercise its responsibility to ensure the APIs manufactured at the facility comply with CGMP.

FDA says the facility lists various APIs under its manufacturer registration that are not referenced in its response to the records request. It advises Nanjing that a redacted item is not an API permissible for use in human drug compounding. FDA placed all of the firm’s drugs offered for import into the U.S. on a 6/22 Import Alert.

Nanjing Hanxin was told to promptly address the deviation and ensure that appropriate resources are allocated to fully address it and prevent its recurrence.