FDA 483 - Hubei Gedian Humanwell Pharmaceutical Co., Ltd. - June 28, 2019

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from June 24 to June 28, 2019, Hubei Gedian Humanwell Pharmaceutical Co., Ltd., an API manufacturer located in Ezhou, Hubei, China, received a Form FDA 483. This document details observations of conditions that may indicate non-compliance with regulatory requirements. The inspection revealed inadequate preventive maintenance procedures for critical manufacturing tanks. Specifically, inspectors observed that several tanks contained loose plastic tape pieces used to secure seals during previous maintenance, with one instance dated August 14, 2018. The company's Workshop Director acknowledged this practice. Additionally, another tank was found to have an old and worn-out seal during the inspection on June 24, 2019, despite having undergone maintenance in August 2018.These findings highlight deficiencies in maintaining the integrity of manufacturing equipment, which is fundamental to ensuring product quality and safety in pharmaceutical production. Hubei Gedian Humanwell Pharmaceutical Co., Ltd. is expected to respond to the FDA 483 by evaluating the root causes of these observations and promptly implementing comprehensive corrective and preventive actions. The objective is to bring operations into compliance with good manufacturing practices and prevent potential risks to product quality.