FDA WARNING_LETTER - InfuScience, Inc. dba Bioscrip Infusion Services - July 30, 2019

This is an amended FDA Warning Letter (WL # 285620) issued to InfuScience, Inc. dba BioScrip Infusion Services, following an inspection from July 23-30, 2019. The inspection revealed serious deficiencies in sterile drug product production, leading to adulterated drug products under FDCA Section 501(a)(2)(A).

Key violations include: 1. Personnel not disinfecting/changing gloves after high-risk activities before resuming aseptic processing. 2. Inadequate smoke studies under dynamic conditions for ISO 5 areas. 3. Facility design allowing air influx from unclassified to classified areas. 4. Failure to adequately segregate, clean, and deactivate surfaces/utensils when producing beta-lactam drugs to prevent cross-contamination. 5. Blocking first pass air in ISO 5 hoods during aseptic production. 6. Failure to disinfect materials/supplies before entering ISO 5 areas from ISO 7 areas. 7. Inconsistent disinfectant contact time and coverage. 8. Visibly dirty ISO 5 classified LAF hoods (e.g., "staining" on HEPA grates). 9. Inadequate personnel monitoring (no fingertip testing, media fill qualifications for nurses, or gown sampling).

The FDA reviewed the firm's August 19, 2019, response