FDA 483 - Hebei Shengxue Dacheng Pharmaceutical Co., Ltd. - April 05, 2024

Hebei Shengxue Dacheng Pharmaceutical Co., Ltd. in Shijiazhuang, China, was issued a Form 483 with seven observations following an FDA inspection. The firm demonstrated significant deficiencies in laboratory controls, including inadequate stability testing methods and OOS investigations. Additionally, issues were noted with equipment qualification, process validation, drug substance storage conditions, and adherence to cleaning and maintenance procedures.