(b)(4).Additional information was requested and the following was obtained: please verify, did the label of the outer or secondary packaging of this device had lot number j1702661 and upon opening the lot number on the primary package had a different lot j1704906.=> yes.The outer pakcage was for 11232 (thus, 2232) with lot # j1702661.The primary (inner) package was for 11233 (thus, 2233) with lot # j1704906.Are pictures available to depict the issue? => no.Was the product properly sealed when issue was discovered and there is no possibility of it been tampered? => yes.The product was properly sealed when the issue was discovered.
|