FDA 483 - Sun Ten Pharmaceutical Co., Ltd - December 19, 2017

An FDA inspection of Sun Ten Pharmaceutical Co., Ltd. in Taichung City, Taiwan, a dietary supplement manufacturer, revealed issues with equipment design and maintenance. Specifically, the firm failed to use equipment that could be adequately cleaned and properly maintained, citing exposed screw threads and rough welds on direct food contact surfaces of tanks and concentrators. This indicates a moderate severity finding related to manufacturing practices.