Product complaint #: (b)(4).Date sent to the fda: 01/22/2020.Additional information: d10.H3 evaluation: upon visual inspection of video, an open overwrap of product could be observed.One partially open sample of product was returned for analysis.During visual inspection of the sample, the overwrap was partially open of the peel-able area.The seal mark was present at the copolymer and tyvek which indicate that the package was sealed.Also the seal margin met the requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.No conclusion could be reached as to what may have caused the reported incident.
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