CGMP Issues Cited at Hubei Gedian Humanwell

An 11/3-11/7/2025 FDA inspection at the Hubei Gedian Humanwell Pharmaceutical Co. drug manufacturing facility in Ezhou City, Hubei Province, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 6/3 Warning Letter says the specific deviations were:

• failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the API beyond the official or other established specifications; and
• failure of the firm’s quality control unit to exercise its responsibility to ensure that manufactured APIs comply with CGMPs.

Hubei was told to correct the deviations promptly and to respond with a list of specific actions it has taken to address the deviations and prevent their recurrence, with a schedule for completing the corrections.