FDA 483 - Overton Brooks VA Medical Center - December 18, 2024

An FDA inspection of Overton Brooks VA Medical Center, a producer of sterile and non-sterile products in Shreveport, LA, was conducted from December 10-18, 2024. The inspection revealed three observations.

Observation 1: Hazardous drugs were produced without adequate containment, segregation, and/or cleaning to prevent cross-contamination. Specifically, on December 11, 2024, a pharmacist retrieved a Fluorouracil vial from a hazardous waste bin, wiped it, and attempted to use it for production. The pharmacist did not perform decontamination and deactivation cleaning steps in the ISO-5 work area after retrieving the vial. The drug product was subsequently remade and administered to an immunocompromised veteran.

Observation 2: Personnel infrequently changed and sanitized gloves, leading to potential contamination. Multiple instances were observed on December 11, 2024, in the chemo buffer room: - A pharmacist returned to the ISO-5 hood without sanitizing gloved hands after disposing of vials and components. - A pharmacist removed hands from the ISO-5 environment to verify a label and returned without sanitizing. - A pharmacist adjusted their face mask twice and returned to the ISO-5 hood without sanitizing gloves. - A pharmacist picked up a fallen shoe cover from the floor, then touched a pass-through door and returned to the ISO-5 environment without sanitizing or changing gloves. - During glove changes, the pharmacist