FDA 483 - Shanghai Tianyuan Plant Products Co., Ltd. - May 06, 2019

An FDA inspection of Shanghai Tianyuan Plant Products Co., Ltd., a dietary supplement manufacturer, revealed significant deficiencies in their sanitation program, including widespread debris and inadequate handwashing facilities. The firm also lacked proper dietary supplement training, leading to issues with product identity, incomplete batch records, and insufficient electronic laboratory controls. These observations indicate a failure to maintain adequate control over manufacturing processes and product quality.