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

The FDA issued a warning letter to CareFusion 213, LLC (a subsidiary of Becton, Dickinson and Company) following an inspection of its El Paso, Texas, facility from October 15 to 24, 2025. The document outlines significant violations of Current Good Manufacturing Practice (CGMP) regulations, particularly regarding sterile drug products. Main issues include the company"s failure to adequately investigate over 2,500 customer complaints involving mold, foreign matter, and packaging defects. The FDA also noted a lack of scientific verification for sterilization indicators and identified systemic cleaning failures, such as the presence of debris and chemical residues in production areas. These findings represent recurring deficiencies previously cited in 2016 and 2023, indicating insufficient management oversight. To address these violations, the FDA requires CareFusion to hire independent experts to perform comprehensive audits of its quality systems, investigative procedures, and cleaning protocols. The company must conduct a three-year retrospective review of complaints and provide a detailed plan for improving its corrective and preventive action (CAPA) programs. Failure to implement these remediations promptly may result in legal action, including product seizures or the withholding of export certificates.