# FDA 483 - Baxter Healthcare Corporation - June 09, 2022

Source: https://www.keypedia.com/records/483/baxter-healthcare-corporation/241a2569-fb3a-4bff-89f7-82b925b3456f

> FDA 483 for Baxter Healthcare Corporation on June 09, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Healthcare Corporation
- Inspection Date: 2022-06-09
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Baxter Healthcare Corporation revealed that procedures for corrective and preventive action (CAPA) were not adequately established. The firm failed to initiate necessary software updates for marketed Voalte Nurse Call software to address a design requirement non-adherence, despite an informal plan and a related nonconformance evaluation. This indicates a significant lapse in their quality system regarding product corrections and preventive measures.

## Related Documents

- [483 - 2010-03-29](https://www.keypedia.com/records/483/baxter-healthcare-corporation/66a1f391-fcc8-4440-b025-804af888d19b)
- [483 - 2016-09-28](https://www.keypedia.com/records/483/baxter-healthcare-corporation/37a42605-354d-43f4-a6ea-fe8429351fda)

## Related Officers

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

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

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