FDA 483 - Hangzhou Karic Commodities Co., Ltd. - March 29, 2018

An FDA inspection of Hangzhou Karic Commodities Co., Ltd. in Hangzhou, China, a drug product manufacturer, revealed 12 significant deficiencies in their manufacturing and quality control processes. The firm failed to adequately test drug products and components, validate manufacturing and cleaning processes, conduct stability studies, and maintain proper documentation and equipment calibration. These issues indicate a severe lack of adherence to Good Manufacturing Practices for drug products distributed to the US market.