FDA 483 - North China Pharmaceutical Huasheng Co., LTD - August 10, 2018

An FDA inspection of North China Pharmaceutical Huasheng Co., Ltd., an Active Pharmaceutical Ingredients manufacturer, revealed significant deficiencies across multiple areas. The firm failed to adequately validate critical manufacturing processes, ensure the suitability of water used in API production, and maintain proper cleaning and storage of equipment and utensils. These issues indicate a lack of robust quality control and could compromise product quality.