FDA 483 - InfuScience, Inc. dba Bioscrip Infusion Services - October 08, 2021

An FDA inspection of InfuScience, Inc. dba Bioscrip Infusion Services in Chantilly, VA, identified critical deficiencies in aseptic processing and environmental controls. Observations included visibly dirty equipment in ISO 5 areas, improper aseptic manipulations that blocked first-pass air, and inadequate certification of cleanroom conditions. The facility's media fills were also found to be insufficient in simulating actual production operations and lacked proper controls.