FDA 483 - Zhejiang Jinhua Conba Bio-pharm. Co., Ltd. (Jinxi) - January 10, 2025

Zhejiang Jinhua Conba Bio-pharm, Co., Ltd., an API manufacturer in Jinhua City, China, was cited for significant deficiencies during an FDA inspection. Observations included inadequate validation of analytical methods for drug substances, insufficient controls over computerized systems leading to potential data manipulation, and failure to ensure equipment cleanliness before use, with residue found after cleaning. These issues indicate a lack of robust quality control and data integrity practices.