FDA 483 - Hubei Biocause Heilen Pharmaceutical Co., Ltd. - November 14, 2025

Hubei Biocause Heilen Pharmaceutical Co., Ltd. in Jingmen, China, received a Form FDA 483 with four observations during an inspection from November 10-14, 2025. The firm was cited for inadequate maintenance of API manufacturing equipment, insufficient evaluation of cleaning effectiveness, deficient system performance qualification, and failure to adequately evaluate drug product testing instruments. These findings highlight significant concerns regarding the firm's control over its manufacturing processes and quality systems for Active Pharmaceutical Ingredients.