FDA 483 - InfuScience, Inc. dba Bioscrip Infusion Services - October 08, 2021
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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.
- Inspection Date
- October 8, 2021
- Product Type
- Drugs
ID · 3226c5db-63d0-459f-bb21-b832873bc71e