# FDA 483 - Baxter Healthcare Corporation - September 28, 2021

Source: https://www.keypedia.com/records/483/baxter-healthcare-corporation/26f092d5-9680-463f-86ca-1a381d7f110c

> FDA 483 for Baxter Healthcare Corporation on September 28, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Healthcare Corporation
- Inspection Date: 2021-09-28
- Product Type: device
- Office Name: New York District Office
- Summary: An FDA inspection of Baxter Healthcare Corporation in Medina, NY, a medical device manufacturer, revealed a significant deficiency in their software validation processes. The firm failed to adequately perform regression testing for software updates on their Spectrum IQ and Spectrum Infusion Pumps, which were released to address recall-related issues. Additionally, their procedures lacked clear requirements for regression testing or documented justifications for its omission.

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## Related Officers

- [Matthew D. Schnittker](https://www.keypedia.com/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.keypedia.com/companies/baxter-healthcare-corporation/1e768fbd-cf7e-4a32-a9dd-c203b45c5613

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d