FDA 483 - Jiangsu NHWA Pharmaceutical Co., Ltd. - September 01, 2023

An FDA inspection of Jiangsu NHWA Pharmaceutical Co., Ltd., an API manufacturer in Xuzhou, Jiangsu, China, revealed significant deficiencies in its quality system. The firm failed to adequately investigate customer complaints regarding foreign particles in APIs and did not properly qualify its contract testing laboratories. Additionally, raw materials and APIs were not stored under appropriate temperature and humidity conditions, leading to multiple excursions.