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

Source: https://www.keypedia.com/records/483/baxter-healthcare-corporation/585e1692-83f5-49e5-90e4-2bd0b52ad702

> 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: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Baxter Healthcare Corporation in Medina, NY, identified inadequate validation of medical device software. Specifically, the firm failed to perform regression testing for several Spectrum Infusion Pump software updates, which were released to address issues related to recalls. This deficiency indicates a significant lapse in ensuring software changes do not introduce unintended consequences.

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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/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961