# FDA 483 - Baxter Healthcare Corporation - November 25, 2025

Source: https://www.keypedia.com/records/483/baxter-healthcare-corporation/195c262e-ca8e-4c23-8651-c58f69d9025c

> FDA 483 for Baxter Healthcare Corporation on November 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Healthcare Corporation
- Inspection Date: 2025-11-25
- Product Type: drugs
- Office Name: FDA District Office — Chicago, Illinois
- Summary: The FDA inspected Baxter Healthcare Corporation in Round Lake, IL, a contract laboratory, and issued a Form 483 with five observations. The inspection revealed significant deficiencies in laboratory controls, quality control unit oversight, computer system controls, personnel training, and laboratory record-keeping. These issues primarily concern environmental monitoring, cross-contamination risks, and data integrity for drug products.

## Related Documents

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- [WARNING_LETTER - 2013-04-19](https://www.keypedia.com/records/warning_letter/baxter-healthcare-corporation/2c84645f-670e-4602-a16f-b56744173190)
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## Related Officers

- [Shafiq Ahadi](https://www.keypedia.com/people/shafiq-ahadi/593bbf28-02e6-47bb-86c3-65cbd4ec520d)

Company: https://www.keypedia.com/companies/baxter-healthcare-corporation/3a2bb12d-f7e5-4c09-9678-b4bec58553a9

Office: https://www.keypedia.com/offices/fda-district-office-chicago-illinois/62c2811c-10c5-4d74-99d0-eb5047ef3b65