Infusion Partners, LLC – FDA 483, Jan 26, 2018

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