# FDA WARNING_LETTER - CareFusion 303, Inc. - May 22, 2024

Source: https://www.keypedia.com/records/warning_letter/carefusion-303-inc/ac8b65c0-fcdf-4886-b883-966cf930161a

> FDA WARNING_LETTER for CareFusion 303, Inc. on May 22, 2024. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: CareFusion 303, Inc.
- Inspection Date: 2024-05-22
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: The FDA issued a Warning Letter to the firm following a May 6-22, 2024, inspection in San Diego, California, concerning its Pyxis Medication Management System medical devices. The devices were found adulterated under section 501(h) due to non-conformity with Quality System regulation (21 CFR Part 820), and the firm's responses were deemed inadequate. Key violations include the failure to establish and implement corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), evidenced by numerous open, severe software defect tickets. The firm also failed to establish adequate complaint handling procedures (21 CFR 820.198(a)), with thousands of complaints lacking proper investigation or MDR evaluation, including those related to patient harm and electrical safety. Design validation was deficient, lacking adequate risk analysis (21 CFR 820.30(g)) for high-severity risks like patient death and cybersecurity vulnerabilities. Furthermore, the firm failed to submit Medical Device Reports (MDRs) within 30 days for malfunctions likely to cause death or serious injury (21 CFR 803.50(a)(2)), with multiple instances of delayed reporting. Lastly, the firm failed to submit Reports of Correction or Removal within 10 working days for actions addressing health risks (21 CFR § 806.10), such as product advisories and software updates. The FDA requires a written response within fifteen business days detailing specific corrective actions, a timetable, and evidence of implementation. Failure to address these violations may result in regulatory actions, including seizure, injunction, civil money penalties, and impact on federal contracts, device approvals, and Certificates to Foreign Governments.

## Related Officers

- [Vipul Sheth](https://www.keypedia.com/people/vipul-sheth/b1d78c1c-2593-4cde-90a5-becab9c3fee0)
- [Raymond W. Brullo](https://www.keypedia.com/people/raymond-w-brullo/c3500ac9-8d22-4c49-b416-8786d548eb93)
- [Connor L. Bates](https://www.keypedia.com/people/connor-l-bates/e3801349-0d8e-42e5-abb4-93cb33d19487)
- [Office Director](https://www.keypedia.com/people/sean-m-boyd/e9ac4789-b489-402d-8fb7-e20eed2af01f)
- [Compliance Officer](https://www.keypedia.com/people/jeffrey-r-wooley/f46f663f-0f2e-4a07-98aa-ecaa43aace35)

Company: https://www.keypedia.com/companies/carefusion-303-inc/ca9b1654-7fcd-406b-9803-d1852781b14a

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7