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

The FDA conducted an inspection of Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd., located at 288 Jinqu Road, Jinhua, Zhejiang, China, from April 21 to April 28, 2025. The facility, which manufactures active pharmaceutical ingredients (APIs) and finished dosage forms, was found to have significant compliance issues related to equipment and utensil maintenance. The inspection revealed that the company's quality and production units failed to ensure proper cleaning and maintenance of equipment, which could lead to contamination affecting the safety, identity, strength, quality, or purity of drug products.

Key observations included the presence of residues in various equipment and areas, such as discharge ports and waste bins, despite records indicating that appropriate cleaning procedures (Type B and Type C) had been performed. These lapses suggest inadequate oversight and execution of cleaning protocols, potentially compromising product integrity.

The FDA's observations are preliminary and do not represent a final compliance determination. The company is expected to address these issues by implementing corrective actions to enhance cleaning and maintenance practices, ensuring compliance with regulatory standards. Mr. Yinguang Li, Vice General Manager, was the recipient of the report, and the company is encouraged to discuss objections or corrective plans with the FDA.