FDA 483 - Richmond VA Medical Center - May 12, 2026

An FDA inspection of the Richmond VA Medical Center in Richmond, VA, conducted from May 5 to May 12, 2026, revealed several significant safety and cleanliness violations at their sterile drug production facility. The investigators observed personnel repeatedly compromising the sterile environment by blocking filtered airflow with their hands and bodies during the preparation of intravenous bags. Additionally, staff members were found leaning into sterile workstations with exposed skin and hair, and moving too quickly within critical areas, which can introduce contaminants.

Further issues were identified regarding cleaning and disinfection practices. Staff failed to properly disinfect equipment like scanners and touchscreens when moving between different areas of the pharmacy. Cleaning techniques were also deemed insufficient, as personnel used improper wiping motions and failed to allow disinfectants the necessary contact time to kill germs. Structural concerns were noted as well, specifically a loose light fixture that could harbor bacteria. Finally, the facility"s airflow testing did not adequately simulate real-world working conditions, failing to prove that the air remains sterile during actual drug production.

These findings were issued under the Federal Food, Drug, and Cosmetic Act. The medical center is required to address these observations by implementing corrective actions and may submit a formal response to the FDA detailing their plan to resolve these deficiencies and ensure the safety of their sterile products.