FDA 483 - Jennifer Moreno Department of Veterans Affairs Medical Center - May 08, 2026

Between April 27 and May 8, 2026, the FDA inspected VA San Diego Healthcare Systems, a producer of sterile drug products. The inspection, conducted under the Federal Food, Drug, and Cosmetic Act, identified several critical safety and cleanliness violations. Primary concerns included inadequate airflow studies that did not reflect real-world production conditions and insufficient segregation of beta-lactam drugs, which poses a significant risk of cross-contamination. Investigators also observed visible staining on HEPA filters and various lapses in sterile technique. Specifically, staff were seen resting on sterile work surfaces, using expired gloves, and failing to disinfect equipment or gloves after touching non-sterile items like keyboards. Additionally, the facility failed to maintain clean environments, with reports of chipped paint and uncleaned overhead sprinklers in production areas. These findings suggest that medications were prepared under conditions that could compromise their sterility. Although this report is not a final determination of non-compliance, the firm is required to respond. VA San Diego Healthcare Systems must discuss any objections with the FDA and submit a formal plan detailing corrective actions taken to address these sanitary and procedural deficiencies.