FDA 483 - Lt Col Luke Weather Jr Veterans Affairs Medical Center (113) - June 04, 2026

From May 27 to June 4, 2026, the FDA inspected the Lt Col Luke Weather Jr Veterans Affairs Medical Center in Memphis, Tennessee, a facility producing sterile drug products. The inspection revealed several critical violations regarding sterile compounding practices and facility maintenance. Primary issues included personnel obstructing the "first air" flow necessary for sterility during drug preparation, inadequate gowning that left skin and hair exposed near sterile zones, and rapid movements by staff that could disrupt protective air barriers. Furthermore, the facility failed to properly disinfect supplies and equipment between production cycles and utilized sterile wipes that had been compromised by exposure to lower-quality air. Technical deficiencies were also noted in the facility"s safety simulations; "smoke studies" meant to visualize airflow were poorly executed, and mandatory safety tests (media fills) did not accurately reflect the actual volumes or complexity of real-world drug production. Additionally, the physical environment showed signs of neglect, including chipped paint and uncleaned sprinkler heads located directly above sterile workstations. These observations were issued under Section 704 of the Food, Drug, and Cosmetic Act due to concerns that medications were prepared under insanitary conditions. The facility is required to respond to these findings by submitting a formal plan for corrective actions or documenting their objections to ensure future compliance with safety regulations.