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

Source: https://www.globalkeysolutions.net/records/483/carefusion-303-inc/9ca517a6-d26a-4185-849d-83053b2efdd3

> FDA 483 for CareFusion 303, Inc. on May 22, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CareFusion 303, Inc.
- Inspection Date: 2024-05-22
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Documents

- [483 - 2018-09-06](https://www.globalkeysolutions.net/records/483/carefusion-303-inc/2b146def-bcb7-4763-bebb-47a0f2ecc22d)
- [483 - 2020-04-06](https://www.globalkeysolutions.net/records/483/carefusion-303-inc/6fb77e5f-514f-4201-a4d9-a5cc5866ed99)
- [483 - 2020-04-06](https://www.globalkeysolutions.net/records/483/carefusion-303-inc/f7ef7fac-ae70-4f01-8c52-6cfc2245a331)

## Related Officers

- [Linda Galindo](https://www.globalkeysolutions.net/people/linda-galindo/6bc29df6-192b-4d89-92ae-20cc1660d9ad)
- [Investigator](https://www.globalkeysolutions.net/people/janet-pulver/d46b01cd-8c3d-4a54-bb91-843e0f94de89)

Company: https://www.globalkeysolutions.net/companies/carefusion-303-inc/e44e5a89-d532-4564-ac5f-1aff2b7d8974

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6