Event description: the customer reported 3 bags of 10 plates each being affected by contamination.Complaint history: complaint history has been reviewed for a period of 12 months and no similar complaint was recorded for this batch number.Dhr review: the bhr was reviewed.No deviations from validated processes were registered.Return sample review: retain samples were analyzed.No deviation was registered.Return samples were provided; however pictures illustrating the complained issue were shared.Evaluation results: aseptic manufacturing processes are unable to guarantee sterility of the given product.Since a 100 % inspection is not possible for aseptic products, sterility testing carried out on the basis of a representative sample.Therefore, occasional contamination cannot be prevented.Since no trend was observed a systematic in our validated manufacturing process can be excluded.A definite root cause could not be determined.Investigation conclusion: based on the internal investigation and the picture samples provided, this complaint was confirmed for contamination.Bd will continue to monitor incoming complaints for similar defect types and apologizes for the inconveniences you have been experiencing due to this issue.
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