FDA 483 - Jiangsu Grand Xinyi Pharmaceutical Co., Ltd - September 09, 2019

Jiangsu Grand Xinyi Pharmaceutical Co., Ltd, an intermediate drug substance manufacturer in Yancheng, China, was cited for significant deficiencies in laboratory controls, investigation procedures, cleaning validation, equipment maintenance, water testing, and incoming material identity testing. The inspection revealed a pattern of inadequate procedures, incomplete investigations, and subjective decision-making that compromises product quality and purity. These issues indicate a lack of robust quality systems necessary for GMP compliance.