FDA 483 - Luoyang MuChun Pharmaceutical Co., Ltd. - December 06, 2019

An FDA inspection of Luoyang Mincun pharmaceutical Co., LTD, an OTC manufacturer, revealed significant deficiencies in their batch production and control records for Pain Relieving Cream. Observations included incomplete record information, lack of proper verification for component additions and yield calculations, and failure to identify personnel for significant steps. Additionally, the firm failed to investigate out-of-specification results and lacked hot water in handwashing facilities.