FDA 483 - Zhejiang Lepu Pharmaceutical Co., Ltd. - December 07, 2018

Zhejiang Lepu Pharmaceutical Co., Ltd. in Taizhou City, China, was inspected by the FDA from December 3-7, 2018. The inspection revealed significant deficiencies in laboratory controls, specifically regarding the validation of test procedures for Active Pharmaceutical Ingredients (API). Additionally, the firm failed to store drug products under appropriate temperature conditions, potentially affecting their quality.