FDA 483 - ImprimisRx NJ - April 09, 2019

An FDA inspection of ImprimisRx in Ledgewood, NJ, identified a critical issue with the aseptic processing environment. The ISO 7 Filling Room, used for sterile ophthalmic and injectable drug products, was found to have inadequately constructed ceiling tiles that moved during cleaning, compromising aseptic conditions. This poses a risk to the sterility of manufactured drug products.