Initial reporter facility name: (b)(6) medicine.The actual device was not available; however, six (6) retained samples were evaluated.Visual inspection was performed and no issues were noted.Two samples were under water leak tested with no issues noted.The reported condition was not verified.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.
|