FDA 483 - Shandong Anxin Pharmaceutical Co., Ltd. (Laoling site) - January 13, 2023

Shandong Anxin Pharmaceutical Co., Ltd, an Active Pharmaceutical Ingredient manufacturer in Dezhou, Shandong, was cited for a significant quality system deficiency. The inspection revealed that the firm lacks a scientifically sound cleaning validation program for its active pharmaceutical ingredients. This includes failing to thoroughly assess the most difficult product to clean for non-dedicated equipment.