Hubei Gedian Humanwell Pharmaceutical Co., Ltd. – FDA 483, May 13, 2016

During an inspection conducted from May 9 to May 13, 2016, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Hubei Gedian Humanwell Pharmaceutical Co., Ltd., an Active Pharmaceutical Ingredient (API) and API intermediate manufacturer located in Ezhou, Hubei, China. The inspection identified two significant observations related to the firm's adherence to good manufacturing practices. Firstly, the FDA noted a failure to adequately calibrate specific manufacturing equipment according to actual operating conditions, which is crucial for ensuring the reliability and accuracy of production processes. Secondly, the inspection revealed that the company did not conduct cleaning of Sampling Room #1 and #2 in accordance with its own established standard operating procedures. These observations highlight deficiencies in the company's quality control and operational procedures, which are fundamental to maintaining product quality and safety under the regulatory framework for pharmaceutical manufacturing. While the Form 483 lists observations and is not a final determination of compliance, Hubei Gedian Humanwell Pharmaceutical Co., Ltd. is expected to promptly address these issues, discuss any objections, or submit plans for corrective actions to the FDA to ensure full compliance with regulatory requirements.