FDA 483 - Hubei JXBio Pharmaceutical Co., Ltd - March 14, 2025

Hubei JXBio Pharmaceutical Co., Ltd., an API manufacturer in Xianning, China, was cited for significant deficiencies in its handling of deviations and out-of-specification (OOS) investigations. The inspection revealed that discrepancies were not clearly documented, explained, or thoroughly investigated. Issues included improper CAPA implementation, unreferenced OOS conclusions, and incomplete root cause analyses.