FDA 483 - Jiangsu Hansoh Pharmaceutical Group Co., Ltd - June 13, 2019

An FDA inspection of Jiangsu Hansoh Pharmaceutical Group Co. Ltd. in Lianyungang, China, a finished drug product manufacturer, revealed significant deficiencies in their production and process control systems. Observations included a lack of written procedures for assuring drug product quality, failure to follow established procedures, and inadequate validation of manufacturing processes. The firm also lacked appropriate sampling procedures for incoming components, indicating a broad failure in quality assurance.