Additional information was provided in sections h.6., and h.10.Complaint trending reviewed for the lot code provided.There were five similar complaints found.There was no sample returned for evaluation.The complaint condition could not be confirmed.Batch records were reviewed and all testing results met specifications for this lot code at the time of release.Additionally, there were no deviations noted during batch record review.As no manufacturing related issues were identified and no sample is available, a conclusive root cause could not be determined.All batches are released according to the required specifications.Based on the complaint information and the investigation results, we can conclude that the disposition of the product remains unchanged.As no product is returned and/or insufficient product data is available, the complaint could not be verified and therefore no corrective and preventive action is initiated.However further trending is performed the manufacturer internal reference number is: (b)(4).
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