FDA 483 - HomeChoice Partners dba BioScript Infusion Services - August 09, 2021

An FDA inspection of HomeChoice Partners dba BioScrip Infusion Services in Augusta, GA, identified two significant observations related to the production of sterile drug products. The firm was cited for using non-sterile disinfecting agents and cleaning practices that pose a risk to product sterility, and for lacking adequate smoke studies performed under dynamic conditions to mimic aseptic processing. These issues indicate potential deficiencies in maintaining aseptic environments and practices.