FDA 483 - John L. McClellan Memorial Veterans Hospital - January 21, 2020

John L. McClellan Memorial Veterans Hospital in Little Rock, AR, was cited for significant deficiencies in its sterile drug product manufacturing operations. The inspection revealed multiple issues related to aseptic processing, environmental control, facility design, and personnel practices, indicating a lack of adequate controls to prevent contamination. These observations highlight a serious risk to the sterility and quality of compounded sterile products.