Product complaint # pc-(b)(4).An unopened sample of product was returned for analysis.During the visual inspection of unopened sample, a pin hole on the tyvek of overwrap was observed; due to the tip of the needle it sees exposed outside the package.Therefore, compromised the sterile barrier.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition, the assignable cause of packaging integrity, is pin hole on package.
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