FDA 483 - Option Care Enterprises - June 28, 2016

The FDA Form 483 details multiple deficiencies in aseptic processing areas, environmental monitoring, personnel gowning, and adherence to sterile drug preparation procedures.

**Facility and Operations:** The inspection observed issues in ISO 5 hoods, ISO 7 clean rooms (IV room), and ISO 8 anterooms, where sterile drug preparation occurs, including TPN and Nafcillin.

**Violations and Observations:** * **Aseptic Processing:** Non-sterile disinfectants and wipes were used for cleaning ISO 5 hoods and ISO 7 rooms. Laminar flow hoods exhibited rust, white crusted material, discolored/furrowed/soiled pre-filters, open containers of liquids, and open sterile syringe packaging. Cords ran from inside hoods to the floor. Workbench surfaces were unclean with powdery/crusted residues. Carts used for material storage were cluttered and had residues. * **Environmental Monitoring:** Infrequent monitoring of differential pressures between ISO 7 (negative pressure), ISO 7 (IV room), ISO 8 anteroom, and unclassified multi-purpose room. Differential pressure records from 01/2016 to 06/2016 showed inconsistent recordings, and there was no alarm system for pressure imbalances. * **Personnel Gowning:** Gowning components (hairnets, face masks, gowns/jumpsuits, disposable lab coats) were non-sterile, except for sterile gloves. Gowning