# FDA 483 - Baxter Healthcare Corporation - April 04, 2025

Source: https://www.keypedia.com/records/483/baxter-healthcare-corporation/2a29d555-f729-43bb-a44e-f0d1d2376c75

> FDA 483 for Baxter Healthcare Corporation on April 04, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Healthcare Corporation
- Inspection Date: 2025-04-04
- 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 two significant observations. The firm's procedures for corrective and preventive actions were found to be inadequately established, particularly concerning investigations and corrective actions for product recalls. Additionally, the company's complaint handling system was cited for insufficient investigations and untimely processing and reporting of medical device reports.

## Related Documents

- [483 - 2021-09-28](https://www.keypedia.com/records/483/baxter-healthcare-corporation/26f092d5-9680-463f-86ca-1a381d7f110c)
- [483 - 2021-09-28](https://www.keypedia.com/records/483/baxter-healthcare-corporation/585e1692-83f5-49e5-90e4-2bd0b52ad702)

## 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