FDA 483 - Hubei JXBio Pharmaceutical Co., Ltd - March 10, 2025

Hubei JXBio Pharmaceutical Co., Ltd. was subject to an FDA inspection from March 10-14, 2025, during which significant deficiencies in their quality management system were observed. The primary finding indicated that the company failed to clearly document, explain, or thoroughly investigate deviations and out-of-specification (OOS) results in their production discrepancy reports. Specific examples highlighted included the improper implementation of a corrective and preventive action (CAPA), such as replacing electronic scales without following established change control procedures, after an OOS event related to balance use. Further issues involved inadequate cross-referencing between related OOS and deviation investigations, as well as investigations that lacked clear documentation of discrepancies, failed to adequately explain root cause determination processes, or did not extend to all potentially affected batches. In one instance, an OOS investigation was prematurely closed before the root cause and CAPA for a newly identified impurity OOS were determined, without initiating a separate investigation for this new finding. These observations, issued by the FDA, require Hubei JXBio to address the identified issues and implement robust corrective actions to ensure compliance with regulatory expectations for an Active Pharmaceutical Ingredient (API) manufacturer.