# FDA 483 - Carefusion 2200 Inc - October 19, 2022

Source: https://www.globalkeysolutions.net/records/483/carefusion-2200-inc/891113d5-5cda-43cb-87e3-a16b4b98bae4

> FDA 483 for Carefusion 2200 Inc on October 19, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Carefusion 2200 Inc
- Inspection Date: 2022-10-19
- Product Type: device
- Office Name: Chicago District Office
- Summary: Carefusion 2200 Inc, a medical device manufacturer in Vernon Hills, IL, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures and the reporting of recall actions. Specifically, the firm failed to adequately address known product integrity issues for sterilization containers and provided inaccurate information in a recall report to the FDA.

## Related Documents

- [WARNING_LETTER - 2013-11-05](https://www.globalkeysolutions.net/records/warning_letter/carefusion-2200-inc/ee1fb8be-6e65-4443-9c18-e1a87ac4e730)

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.globalkeysolutions.net/companies/carefusion-2200-inc/0709ed08-760c-4fd5-be76-4052df39bf8e

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669