Batch history review: the traceability of articles with batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer.In addition, the raw materials, semi-finished parts, etc.Used for the order are documented in the manufacturing history records (dhr - device history records).This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to the transport and storage of the product.Rationale: according to the information available, the most probable cause of the reported damages of the package are related to transport and storage of the product.As the products are not available for investigation the holes cannot be confirmed, known from other complaint ((b)(4)) it is possible, that deformations on the aluminum package are misinterpreted as holes.Corrective action: capa 700002796 has been conducted and implemented.
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