Fresenius kabi china received a report of potential bacterial contamination.As of the date of this report, the bacterial contamination has not been confirmed and a bacteria has not been identified.If more information is received, a follow-up report will be submitted.
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No sample was returned to fresenius kabi usa for evaluation.Pictures of the platelet bag filled with collected product were observed.However, based on the complaint description, it is not possible to confirm the customer report of bacterial contamination from the provided pictures.The batch record for product code c6r2316, lot fa22d26175 was reviewed.No exceptions were generated that could classify as a possible root cause of this defect.The finished good lot has passed all sampling acceptance criteria for all tests performed including in-process testing and product testing.Root cause: event #1627726 was issued in order to investigate this condition.The amicus microbiology testings were completed with satisfactory results.The bacteria identified in the complaints was not found during the haina plant micro-flora during the manufacturing period of the reported batches.Studies were performed to confirm that the microorganisms reported do not resist the sterilization process.No further investigation is required.Current controls: · microbiology monitoring · product e-beam sterilization · in process sampling quality inspection.· post sterilization sampling final inspection track and trend: no additional complaints for bacterial contamination were received against product code c6r2316, lot fa22d26175.Fresenius kabi china reported a total of 1 bacterial contamination incident against product code: c6r2316, lot fa22d26175.A monthly trend is performed to determine the need to initiate an investigation due to an increase in complaints or to determine if corrective actions are needed.No trend was observed for this defect category.
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