Additional information provided in evaluation codes and additional mfr narrative.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.No sample was returned for evaluation; therefore, the condition of the product could not be verified.A sample was not returned and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.(b)(4).
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