(b)(4).The lot 14j037 was manufactured on september 19, 2014 ¿ september 24, 2014.The device was received for evaluation.Visual and microscopic inspections on the device revealed no evidence of particulate matter either inside or outside of the reservoir.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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