FDA 483 - Sichuan D-Innovation Pharmaceutical Co., Ltd. - March 14, 2025

An FDA inspection of Sichuan D-Innovation Pharmaceutical Co., Ltd. in Meishan City, China, revealed significant deficiencies in their manufacturing processes. The firm failed to adequately validate production systems and evaluate deviations from specified process steps. Additionally, there was no assurance that critical systems used for API manufacture were adequately qualified for their intended use.