# FDA 483 - Infusion Partners, LLC - January 26, 2018

Source: https://www.keypedia.com/records/483/infusion-partners-llc/0a63bf6f-c0b8-41d3-90a6-9dd8cf122c7d

> FDA 483 for Infusion Partners, LLC on January 26, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Infusion Partners, LLC
- Inspection Date: 2018-01-26
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: The FDA Form 483 details multiple observations at a facility producing sterile drugs, including beta-lactam drugs. The inspection revealed significant issues within the ISO 5, ISO 7, and ISO 8 classified aseptic processing areas.

Key observations include:
*   **Equipment and Surface Cleanliness:** Visible whitish and rust-colored residue on HEPA filter guards in ISO 5 laminar airflow hoods, and flaking paint/rust on HEPA filter guards in the ISO 7 cleanroom.
*   **Disinfection Procedures:** Insufficient disinfectant contact time (estimated minutes for sporicide) and inadequate coverage for items being disinfected in ISO 5, ISO 7, and ISO 8 areas.
*   **Aseptic Technique and Airflow:**
    *   Personnel blocked first-pass air during aseptic manipulations.
    *   Sagging HEPA guards in ISO 5 hoods blocked approximately 1/3 of airflow.
    *   Lack of visually recorded smoke studies to demonstrate uninterrupted airflow.
    *   No velocity measurements for airflow in ISO 7 or ISO 5 hoods to assess impact.
    *   Employees performed manipulations and placed filled containers in areas of ISO 5 hoods not covered by laminar airflow.
    *   Employees blocked first-pass airflow over vial stoppers with their hands.
*   **Gloving Practices:** Personnel touched non-aseptic surfaces (keyboard, phone, trash, etc.) with gloved

## Related Documents

- [WARNING_LETTER - 2018-01-26](https://www.keypedia.com/records/warning_letter/infusion-partners-llc/bb536b1c-c05f-4905-9fa7-fdf5352feaaf)

## Related Officers

- [Drug Specialist](https://www.keypedia.com/people/lauren-n-howard/538f77fe-b977-49c9-a5b3-289cf8a6e886)
- [ Investigator ](https://www.keypedia.com/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

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

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22