Investigation summary.It was reported that 150 plates would have show contamination.The complaint trends were reviewed and similar complaints were found for this lot number.Therefore, a mrb (material review board) was performed and this issue will be investigated within a capa (corrective and preventive action) 4344556.The batch history review did not indicate any discrepancies.All release testing was satisfactory, and no deviations were observed.Pictures were provided showing the reported contamination.The retention samples were reviewed and the plates were found to be without deviation.At this stage of our investigation, we have excluded any systemic failure in our manufacturing process.Please note that this product does not have an sal claim.It is filled aseptically, therefore an occurrence of a contamination event cannot be entirely ruled out.We only release product batches to the market with an aql (acceptable quality level) = 1.5.Although this contamination level is very low, we cannot completely exclude that a customer may receive a contaminated plate.As several complaints were reported for this product lot number regarding contamination, a mrb (mrb 22-006) and capa (# 4344556) were created for further evaluation.The root cause investigation is currently ongoing within capa 4344556.Based upon our investigation the complaint was confirmed.
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