This report is being filed to provide additional information in b.5, d.9, h.3, h.6 and h.10.Corrected information is provided in b.3.Investigation: we received red blood cell storage bags only; therefore, we were not able to investigate the filters, which are related to filtration function.In regard to the production of imuflex, sealed bags are filled with solution and the line is assembled.These bags are sterilized, stacked, and placed into the blister trays.The top film of each blister tray is heat-sealed.For the leukoreduction filter, filter membranes are punched out, laminated, and integrated into soft housing.In order to ensure leukoreduction performance and to prevent filter occlusion in and hemolysis, standards have been set to control particulate removal rates and cationization levels of each filter membrane.The standards of average cationization levels of laminated filter membranes have also been set and controlled.We reviewed the manufacturing record of the lot number in question and confirmed that no anomalies occurred in any process, and the products were manufactured as usual.In addition, we investigated dope material used for the lot number in question and found that the viscosity of pu solution of dope material conformed to the standards.Shipping testing, including measurements of solution concentration and volume, and a visual inspection, is performed on the product concerned on a sample basis.We reviewed each testing and inspection record of the production number and confirmed that there were no anomalies in all shipping testing items.The product conformed to the standards.We investigated whether any complaints associated with this lot number and confirmed that we had not received any reports about the same issue by other customers as of september 9, 2022.Root cause: as mentioned above, there were no anomalies in the manufacturing record and the testing and inspection record of the lot number concerned.We were not able to identify the cause of this issue.We were unable to observe the state of the occurrences in the filters, which are related to filtration performance, as the filters were not returned for evaluation.
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