# FDA 483 - Carefusion Corporation - September 19, 2025

Source: https://www.keypedia.com/records/483/carefusion-corporation/cc8f1192-4279-4713-a9de-6442ff65570f

> FDA 483 for Carefusion Corporation on September 19, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Carefusion Corporation
- Inspection Date: 2025-09-19
- Product Type: device
- Office Name: Dallas District Office
- Summary: Carefusion Corporation in Mannford, OK, received one observation during an FDA inspection concerning inadequate procedures for controlling nonconforming product. The firm's procedures contained conflicting guidance for distinguishing between normal process scrap and nonconformance, and they failed to adequately investigate nonconforming product related to welding defects. This indicates deficiencies in their quality system regarding product control and complaint investigation.

## Related Documents

- [483 - 2018-09-28](https://www.keypedia.com/records/483/carefusion-corporation/698c42c8-3793-4bfc-a923-9efdf0363281)

## Related Officers

- [Jamie P. Webb](https://www.keypedia.com/people/jamie-p-webb/9e052469-54f7-4d56-b977-27babbdac09b)

Company: https://www.keypedia.com/companies/carefusion-corporation/fc68c359-74a3-4c78-844a-79b933b81f81

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9