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

During an inspection conducted from October 15-24, 2025, the FDA identified significant deficiencies at CareFusion 213, LLC's manufacturing facility in El Paso, TX. The observations, detailed in an FDA 483, indicate several areas of non-compliance with current Good Manufacturing Practices (cGMP). Key issues included a lack of adequate written procedures and follow-up within the quality control unit, evidenced by insufficient investigations into customer complaints, ineffective Corrective and Preventive Action (CAPA) processes, unvalidated quality metrics spreadsheets, and poor label control. The firm failed to thoroughly investigate product issues like mold contamination and cracks, often not extending inquiries to other relevant batches. Laboratory controls were also found lacking, specifically concerning the absence of scientifically sound test procedures for biological indicators and insufficient documentation during sterility testing. Furthermore, the facility and equipment cleaning programs were inadequate; buildings were not maintained in a clean state, and critical cleaning validation programs for manufacturing areas, assembly lines, sterilization chambers, and formulation equipment were either absent or not followed, with visible product residue observed. Finally, documentation errors were noted, as rejected product data from assembly lines and rejected ampoules from the rinsing process were not consistently captured in batch production records. CareFusion 213, LLC is required to address these serious observations by developing and implementing robust corrective and preventive actions to ensure compliance with regulatory standards.