Chinese API Manufacturer Cited in FDA Form 483

FDA has cited Chinese active pharmaceutical ingredient manufacturer Hubei JXBio Pharmaceutical Co for multiple deficiencies in its handling of deviations and out-of-specification results following a March 2025 inspection, according to a just-posted FDA Form 483. The inspection of Hubei JXBio identified shortcomings in the company’s documentation, investigation and corrective action processes at its facility in Xianning, Hubei, China.

The inspection form outlines four primary observations centered on inadequate investigations of deviations and out-of-specification (OOS) laboratory results. According to FDA, deviations and OOS findings “are not clearly documented, explained, or investigated in production discrepancy reports.”

In one case, investigators found that a deviation opened in 4/2024 after a batch intermediate failed purity specifications was linked to improper use of a balance during material weighing. While the company proposed a corrective and preventive action to replace electronic scales in the workshop with models equipped with printing functions, FDA said the change was not implemented through the firm’s established change control system.

In a separate incident, the company initiated a deviation for a single impurity test result that did not meet requirements for a batch. The agency said the deviation was opened after the closure of a related OOS investigation but failed to reference that prior investigation or its conclusions, raising concerns about traceability and the adequacy of root-cause analysis.

The agency also cited a December 2023 investigation into a batch that did not meet process requirements, stating that the report did not clearly document the discrepancy, explain how the root cause of contamination was determined, or document change control for updates to specifications and test methods. Additionally, the investigation did not extend to assess other potentially affected batches, the agency said.