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

The U.S. Food and Drug Administration issued a Form 483 to Hubei Gedian Humanwell Pharmaceutical Co., Ltd., an Active Pharmaceutical Ingredient (API) manufacturer located in Ezhou, Hubei, China. The inspection, conducted from June 24 to June 28, 2019, identified significant deficiencies in the company's preventive maintenance program for manufacturing equipment. Investigators observed inadequate maintenance of tanks, specifically noting loose plastic tape pieces used to secure seals inside tanks and the presence of old and worn-out seals in certain equipment. These issues indicate a potential compromise in equipment integrity and cleanliness, which are critical for maintaining product quality and safety in accordance with Good Manufacturing Practices (GMP). The company's General Manager, Zheng Cbenggang, was issued the report. While the FDA 483 document highlights objectionable conditions, it does not explicitly state required actions; however, Hubei Gedian Humanwell Pharmaceutical Co., Ltd. is expected to promptly investigate these observations and implement comprehensive corrective and preventive actions to ensure compliance with regulatory standards and prevent future recurrence.