Jiangxi Dongfeng Pharmaceutical Co., Ltd — EU GMP NCR (EudraGMDP) Findings

Overall,28 deficiencies were observed during the inspection, including 4 Major deficiencies: [Major 1] Inapropriate frequency for the microbiological and chemical testing of the steam used for equipment sterilization; [Major 2] Risks of contamination in the manufacturing area of sterile APIs; [Major 3] Failure in the sterilization process and in the microbiological monitoring of the RABS (Restricted Access Barrier System); [Major 4] Failure for the temperature monitoring process during sterilization run for several equipment; [Major 5] Failure for the evaluation and the management of a supplier of the sterile LPDE (Low Density Polyethylene) bags used for the packaging of sterile APIs; [Major 6] Risks of loss of sterility of sterile APIs during the filling process; [Major 7] Use of reusable drums not under control; [Major 8] Failure for the aseptic process simulation test; [Major 9] Failure for the recovery process of solvents. Action taken/proposed by the NCA: Recall of batches already released A recall of products should be considered using QRM principles. Prohibition of supply After issuance of the non-compliance report and as long as it remains active, the site should not be named in any new MAs or used in drug compounding activities.