FDA 483 - CareFusion 303, Inc. - May 22, 2024

CareFusion 303, Inc. was cited for significant deficiencies across its quality system, primarily concerning corrective and preventive actions, complaint handling, MDR reporting, and risk analysis. The inspection revealed issues with Alaris Infusion systems, including a Class I recall due to syringe incompatibility and bent IUI pins, as well as numerous unaddressed software defects in Pyxis systems. The firm also failed to adequately investigate complaints, determine MDR reportability for critical issues, and properly assess risks, including cybersecurity vulnerabilities and postmarket data related to patient harm.