Product complaint # (b)(4).Additional information: d4, g1, h4.The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.Additional h-3 summary: one unopened sample of product code w745, lot mjk308 was received for analysis.During visual inspection of the overwrap packet, the winding former was noted in the overwrap seal area, this caused that sterile barrier was compromising since a section of the seal area was partially open.Per the condition of the sample received the assignable cause of the packaging - integrity is an open seal defect.
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