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

This FDA Form 483 was issued to InfuScience, Inc. dba Bioscrip Infusion Services, a producer of sterile drug products located at 4151 Lafayette Center Dr Ste 600, Chantilly, VA 20151-1230. The inspection occurred from September 27, 2021, to October 8, 2021. Ms. Rebecca L. Harris, Senior Director of Operations, received the report.

The inspection revealed four observations:

1. **Contaminated Aseptic Processing Areas:** The ISO 5 classified aseptic processing areas contained particle-generating and visibly dirty equipment. Specifically, white spots were observed on the HEPA diffuser screens of all (b)(4) laminar air flow hoods in the buffer room on September 27 and October 4, 2021. These spots were not removed before or between aseptic processing of products like "TPN 3:11460 ml IV 15 Hours 6/week," "(b)(4) mg; (b)(4) ml NS Wk 0,2,6, then Q8wk," and "DAPTOmycin 770mg in NS (b)(4) ml Q24H EP."

2. **Blocked First Pass Air:** Personnel conducted aseptic manipulations in a manner that blocked the movement of first pass air around