FDA WARNING_LETTER - Infusion Partners, LLC - January 26, 2018

On March 20, 2019, the FDA issued a Warning Letter to Bioscrip Inc. following an inspection of their Infusion Partners, LLC facility in Canfield, OH, from January 22-26, 2018. The inspection revealed serious deficiencies in sterile drug product manufacturing, leading to adulterated drug products under section 501(a)(2)(A) of the FDCA.

Key violations include: 1. **Inadequate ISO 5 Area Design:** Front work areas in ISO 5 hoods were not directly under HEPA filters, and a smoke study failed to demonstrate laminar airflow protection, despite operators performing aseptic processing there. 2. **Contaminated HEPA Filter Guards:** Visible white and rust-colored residue on ISO 5 hood HEPA filter guards, and flaking paint/rust discoloration on ISO 7 cleanroom HEPA filter guards. 3. **Poor Aseptic Practices:** Operators frequently moved their entire upper body into ISO 5 hoods, moved rapidly near ISO 5 areas, failed to change/disinfect gloves after exiting/re-entering ISO 5 areas, and did not disinfect items moved from unclassified to ISO 7 areas via the (b)(4). 4. **Compromised (b)(4) Between Rooms:** The (b)(4) between the ISO 7 cleanroom and an unclassified room allowed unclassified air influx