Additional information was added to d9, h3, h4, h6, h10.H4: the lot was manufactured from june 23, 2020 - june 24, 2020.H10: two (2) actual samples were received for evaluation.Unaided visual inspection was performed which observed that the primary packaging on the top right side area of the first sample and right side area of the second sample were not sealed.The reported condition was verified.The cause of the condition could not be determined.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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