(b)(4).Fifteen (15) unused, unopened samples, in packaging indicating the reported lot # 0061401741, were received for evaluation.Upon visual observation, the paper backing of the blister package was noted to be torn/ripped on all fifteen samples.Based on the results of this investigation, it could not be definitively determined where in the packaging/shipping/handling process this issue occurred.While no specific conclusions could be drawn, it should be noted that although our packaging is tested to astm standards during development to ensure that they will maintain integrity under normal to strenuous shipping conditions, excessive handling may result in some damage.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.If additional pertinent information becomes available a follow-up report will be filed.
|