Product complaint # pc-(b)(4).An opened overwrap and an empty opened paper folder were returned for analysis.During the visual inspection of the sample it was verified that the packaging was opened.There was no thread or needle inside package, just a paper folder was found inside package.Additionally, no issues were found in the overwrap package.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per sample condition, it could not be determined what may have caused the reported this incident.
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