FDA 483 - CareFusion 213, LLC - September 29, 2023

CareFusion 213, LLC in El Paso, TX, a combination drug/device manufacturer, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in quality control unit procedures, raw material testing, component sampling, facility maintenance, and laboratory controls, including a repeat observation regarding sterility test validation. These issues indicate a moderate level of non-compliance with GMP regulations.