Central Alabama Veterans Health Care System - West Campus – FDA 483, Apr 16, 2026

During an inspection conducted from April 8 to April 16, 2026, the FDA identified significant sterility and safety concerns at the Central Alabama Veterans Health Care System West Campus in Montgomery, Alabama. As a producer of sterile drug products, the facility was found to be in violation of standards required under the Food, Drug, and Cosmetic Act. The primary issues centered on the facility"s failure to ensure a truly sterile environment for drug preparation. Specifically, "media fill" validation tests failed to simulate the most stressful real-world production conditions, and some contamination test samples were discarded or stored improperly for weeks in unmonitored equipment. Airflow visualization studies were also inadequate, failing to prove that sterile work areas were protected during actual staff movements. Further observations included the use of non-sterile cleaning agents in high-protection zones, a lack of proper disinfection when moving supplies between rooms, and visible residue on equipment surfaces. Additionally, the facility failed to monitor air pressure levels and maintained an environment with physical defects, such as cracked ceiling tiles and holes in walls, which could harbor contaminants. This report serves as a preliminary notice of objectionable conditions. The facility is expected to respond to the FDA with a detailed corrective action plan or objections to these findings to ensure future compliance with safety regulations and protect patient health.