FDA 483 - Sichuan Qingmu Pharmaceutical Co., Ltd - September 07, 2021

An FDA inspection of Sichuan Qingmu Pharmaceutical Co., Ltd, an Active Pharmaceutical Ingredient Manufacturer, revealed significant deficiencies in quality unit procedures. The firm failed to perform required performance qualifications for critical manufacturing equipment and improperly classified a critical equipment change as minor. Additionally, the inspection found inadequate written records for investigations into batch failures, specifically concerning discrepancies in Thin Layer Chromatography (TLC) results and missing raw data.