FDA 483 - Hubei Gedian Humanwell Pharmaceutical Co., Ltd (Huanggang Site) - November 19, 2025

An FDA inspection of Hubei Gedian Humanwell Pharmaceutical Co., Ltd. (Huanggang Site), a finished API manufacturer, revealed an inadequate cleaning validation program for manufacturing equipment. The firm lacked a complete Clean Hold Time study, raw data for surface area calculations, and proper justification for campaign cleaning. This inadequacy resulted in observed product residues and stains on equipment contact surfaces.