H.6 investigation summary.Event description: customer reported contamination on the plates as well as a broken dish.Complaint history review: the complaint trends were reviewed and similar complaints were found for this catalog number.A trend was identified; therefore, a mrb (material review board) was performed and this issue will be investigated within a capa (corrective and preventive action).Batch history record (bhr) review: the batch history review did not indicate any discrepancies.All release testing was satisfactory, and no deviations were observed.Sample analysis: retain samples were reviewed and no deviation was observed.Return samples were not provided; however a picture illustrating the contamination was shared.The complained broken dish could not be identified on the shared picture.Evaluation results: 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) = 0,65.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 regarding contamination, a mrb (mrb 22-006) and capa (# 4344556) were created for further evaluation.The root cause investigation is currently ongoing within the mentioned capa.Investigation conclusion: based upon our investigation the complaint was confirmed.
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