FDA 483 - CareFusion 213, LLC - October 24, 2025

An FDA inspection of CareFusion 213, LLC in El Paso, TX, revealed significant deficiencies across multiple quality systems. The firm was cited for inadequate quality control unit procedures, including poor complaint and CAPA investigations, unvalidated spreadsheets, and improper label control. Further issues included insufficient laboratory controls for biological indicators, lack of documentation for sterility testing, unsanitary facility conditions, and unvalidated cleaning procedures for equipment and manufacturing areas.