CareFusion Hit With Warning at Texas Drug Facility

FDA has issued a Warning Letter to CareFusion, a subsidiary of Becton Dickinson, citing widespread and repeat violations of current good manufacturing practice regulations at a Texas facility that produces sterile drug products. The 4/30 letter follows an FDA inspection at the company’s El Paso manufacturing site conducted 10/2025. Regulators said the facility’s manufacturing controls were insufficient to ensure product quality and sterility, rendering its drug products “adulterated” under federal law.

FDA inspectors identified significant breakdowns in the company’s quality systems, particularly in how it investigates product complaints and manufacturing deviations. Since 9/2023, the agency says, the firm has logged more than 2,500 customer complaints involving issues such as foreign particles, suspected mold, missing components, and compromised packaging. CareFusion repeatedly failed to conduct thorough root cause investigations, extend reviews to other potentially affected batches, or implement effective corrective and preventive actions, it says. In several cases, investigations lacked scientific justification or were left incomplete.

FDA also cited deficiencies in out-of-specification investigations, including a sterility failure that led to a product recall. The agency said the company did not adequately assess the scope of a container-closure integrity issue tied to packaging materials, nor did it sufficiently address supplier-related risks.

The Warning Letter highlights ongoing sterility risks at the facility, including a history of recalls and field alerts tied to contamination. Inspectors observed inadequate cleaning practices, visible residue and debris in manufacturing areas, and lapses in environmental monitoring.

In one instance, microbial testing identified Streptococcus pneumoniae — a potentially harmful pathogen — in non-sterile product components. FDA investigators also documented improper gowning practices and multiple environmental monitoring excursions in critical production areas.

The agency warned that such deficiencies are particularly concerning for products that may not undergo terminal sterilization, where aseptic processing controls are essential to ensure sterility.

Additionally, FDA cited failures in laboratory controls, including the company’s use of biological indicators in sterilization processes without ongoing verification of spore populations. The firm relied on initial validation data and qualitative testing rather than routine quantitative checks, undermining confidence in sterilization effectiveness.

The letter noted that similar deficiencies were cited during prior inspections in 2016 and 2023, suggesting persistent compliance failures. FDA concluded that executive management oversight and the authority of the company’s quality unit remain inadequate.

“Procedural updates and training alone do not address the systemic failures,” the agency wrote, directing CareFusion to undertake extensive remediation efforts, including independent assessments of its investigation systems, laboratory controls, contamination controls, and overall process capability. The company must also conduct retrospective reviews of complaints and testing data spanning multiple years.