FDA 483 - Hubei Gedian Humanwell Pharmaceutical Co., Ltd. - November 07, 2025

An FDA inspection conducted from November 3 to November 7, 2025, at Hubei Gedian Humanwell Pharmaceutical Co., Ltd. identified significant concerns regarding facility and equipment maintenance and critical system monitoring. The inspection, which focused on Active Pharmaceutical Ingredients (APIs) for the U.S. market, highlighted two primary observations. Firstly, equipment and manufacturing facilities were not adequately maintained. Specific issues included stained and discolored production vessels, a vessel with significant scratching, a leaking motor on another vessel, and stains around the rim and lid of a processing unit. Furthermore, the facility showed stains on ceilings and ventilation vents, residue on hoses, and unsealed doorways and windows in sensitive production areas, raising questions about contamination control. Secondly, the Air Handling Units (AHU) in an API Workshop lacked essential automatic alarm notification capabilities. This deficiency was evident when an AHU shut down due to elevated moisture, and operators could not immediately respond due to the absence of an automated alert system, potentially impacting product quality and environmental control in clean rooms. These observations, issued on an FDA Form 483, require the company to develop and implement corrective actions to address these deficiencies, ensuring compliance with manufacturing standards for pharmaceutical products.