483
ImprimisRx NJFDA 483 - ImprimisRx NJ - April 09, 2019
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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.
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ID · d2c04a43-2dd3-4e66-b9f0-b343dd87b27a