FDA 483 - Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd. - April 28, 2025

An FDA inspection of Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd. in Jinhua, China, revealed significant deficiencies in equipment and utensil cleaning and maintenance. Inspectors observed various residues and a torn gasket on manufacturing equipment, indicating a lack of adequate oversight to prevent contamination of drug products. These findings suggest a failure to maintain appropriate cleanliness standards within the facility.