# FDA 483 - CareFusion 303, Inc. - April 06, 2020

Source: https://www.globalkeysolutions.net/records/483/carefusion-303-inc/6fb77e5f-514f-4201-a4d9-a5cc5866ed99

> FDA 483 for CareFusion 303, Inc. on April 06, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: CareFusion 303, Inc.
- Inspection Date: 2020-04-06
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: CareFusion 303, Inc. in San Diego, CA, a medical device manufacturer, was inspected by the FDA from March 2 to April 6, 2020. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate corrective and preventive actions, complaint handling, medical device reporting, design verification, servicing procedures, and software validation. These issues were linked to numerous device malfunctions, some resulting in patient deaths or serious injuries, and included a failure to report a major field correction to the FDA.

## 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/f7ef7fac-ae70-4f01-8c52-6cfc2245a331)
- [483 - 2024-05-22](https://www.globalkeysolutions.net/records/483/carefusion-303-inc/9ca517a6-d26a-4185-849d-83053b2efdd3)

## Related Officers

- [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