The device was received for evaluation.Visual inspection was performed and particulate matter (pm) was identified outside the wall of the inner pouch.Inspection under the microscope was performed and the pm was determined to fiber; however, the size of the pm was small enough to meet specification.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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