FDA 483 - Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd. - August 01, 2023

Zhejiang Jinhua Conba Bio-Pharm Co. Ltd. was inspected and cited for significant deficiencies across its manufacturing operations. The inspection revealed issues with facility separation leading to cross-contamination risks, inadequate employee training for visual inspection, and insufficient laboratory controls including media testing. Additionally, the firm lacked established procedures to prevent microbiological contamination of sterile products.