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

Source: https://www.globalkeysolutions.net/records/warning_letter/infusion-partners-llc/bb536b1c-c05f-4905-9fa7-fdf5352feaaf

> FDA WARNING_LETTER for Infusion Partners, LLC on January 26, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Infusion Partners, LLC
- Inspection Date: 2018-01-26
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: 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

## Related Documents

- [483 - 2018-01-26](https://www.globalkeysolutions.net/records/483/infusion-partners-llc/0a63bf6f-c0b8-41d3-90a6-9dd8cf122c7d)

## Related Officers

- [Program Division Director](https://www.globalkeysolutions.net/people/art-o-czabaniuk/37f1e249-9ee6-4275-9c28-391d93659b85)
- [Tonya Sutton](https://www.globalkeysolutions.net/people/tonya-sutton/65c3e214-4e75-4ae8-a0dd-92f007e84621)

Company: https://www.globalkeysolutions.net/companies/infusion-partners-llc/24f0f21b-4680-4111-8c90-a561a1730057

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0