# Baxter Healthcare Corporation – FDA 483, Apr 2, 2026

Source: https://www.keypedia.com/records/483/baxter-healthcare-corporation/b0fda0bf-0fd1-4bc0-9e4b-ff59c52d528d

> FDA 483 for Baxter Healthcare Corporation on April 02, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Healthcare Corporation
- Inspection Date: 2026-04-02
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Baxter Healthcare Corporation's sterile drug manufacturing facility in Round Lake, IL, was cited for significant deficiencies across its quality control and production processes. The inspection revealed failures in thoroughly investigating discrepancies, validating aseptic processes, maintaining adequate visual inspection controls, and ensuring proper equipment design and personnel training. These issues collectively indicate a lack of robust control over manufacturing and laboratory operations, posing risks to product quality and sterility.

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- [483 - 2025-11-25](https://www.keypedia.com/records/483/baxter-healthcare-corporation/195c262e-ca8e-4c23-8651-c58f69d9025c) — date: November 25, 2025
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- [WARNING_LETTER - 2013-04-19](https://www.keypedia.com/records/warning_letter/baxter-healthcare-corporation/2c84645f-670e-4602-a16f-b56744173190) — date: April 19, 2013
- [WARNING_LETTER](https://www.keypedia.com/records/warning_letter/baxter-healthcare-corporation/38c366e8-7c89-43c3-9ec2-0991b551bef7)

## Related Officers

- [Supreet K. Sran](https://www.keypedia.com/people/supreet-k-sran/1dab51f8-b483-4ccb-8b44-89fdc3b8100b)
- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)
- [Investigator ](https://www.keypedia.com/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)
- [Supreet K. Stan](https://www.keypedia.com/people/supreet-k-stan/e18c3560-c523-47e7-b5f0-5f75534ab164)
- [Paranthaman Senthamarai Kannan](https://www.keypedia.com/people/paranthaman-senthamarai-kannan/12221263-b29b-4696-9e6e-84e659ae43cd)

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

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