# FDA 483 - Baxter Healthcare Corporation - March 29, 2010

Source: https://www.globalkeysolutions.net/records/483/baxter-healthcare-corporation/66a1f391-fcc8-4440-b025-804af888d19b

> FDA 483 for Baxter Healthcare Corporation on March 29, 2010. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Healthcare Corporation
- Inspection Date: 2010-03-29
- Product Type: device
- Office Name: Chicago District Office
- Summary: Baxter Healthcare Corp. in Deerfield, IL, was inspected and cited for multiple deficiencies related to its quality system for medical devices. The observations primarily concern inadequate management reviews, incomplete CAPA procedures, failure to implement corrective actions, insufficient analysis of quality data, and issues with supplier controls and quality audits. These issues indicate a systemic breakdown in ensuring product quality and compliance with regulatory requirements.

## Related Documents

- [483 - 2016-09-28](https://www.globalkeysolutions.net/records/483/baxter-healthcare-corporation/37a42605-354d-43f4-a6ea-fe8429351fda)
- [483 - 2022-06-09](https://www.globalkeysolutions.net/records/483/baxter-healthcare-corporation/241a2569-fb3a-4bff-89f7-82b925b3456f)

## Related Officers

- [Lorelei Jarrell](https://www.globalkeysolutions.net/people/lorelei-jarrell/90a645d1-0c9c-4992-8876-1732735e4083)
- [Margaret N. Torres-Vazquez](https://www.globalkeysolutions.net/people/margaret-n-torres-vazquez/ba5ef461-1230-4e51-85a8-a03d7393426d)

Company: https://www.globalkeysolutions.net/companies/baxter-healthcare-corporation/99f38647-05a1-47b9-8628-66fe0bedb146

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