FDA 483 - sentara enterprises - July 14, 2023

An FDA inspection of Sentara Enterprises dba Sentara Infusion Services (Blue Ridge) in Charlottesville, VA, identified five observations related to the production of sterile drug products. The findings indicate significant concerns regarding aseptic processing techniques, environmental control, and validation practices. Issues included improper aseptic manipulations, inadequate disinfection, insufficient media fill simulations, and poorly performed smoke studies.