The inspection team identified 18 deficiencies (grouped) against EU GMP, of which 11 were classified as Major. The major deficiencies were related to: - Inadequacy of Quality Assurance oversight and Quality management system - Inadequate design, poor maintenance/cleaning, lack of contamination control in intermediates manufacturing facilities - Solvent recovery, lack of traceability and risk of cross-contamination - Risk of supplying non-GMP APIs for production of medicinal products for human or animal use - Change control - Data integrity of documentation and records - Traceability and control of material throughout the manufacturing process - Cleaning and process validation - Material management - Insufficient control of analytical methods - Incomplete understanding and incorrect application of fundamental GMP principles Action taken/proposed by the NCA: Suspension or voiding of CEP (action to be taken by EDQM) CEP 2023-042 / Dexamethasone sodium phosphate CEP 2023-086 / Betamethasone CEP 2023-244 / Dexamethasone Crystalline Form-B CEP 2023-305 / Dexamethasone Crystalline Form-A were suspended on July 29, 2026 by EDQM
Inspection Record
Xi'an Guokang Ruijin Pharmaceutical Co. Ltd. — EU GMP NCR (EudraGMDP) Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
1Data integrity
About this record
Extracted automatically from the document EMA (Europe) published on 2026-09-21. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
