# FDA 483 - Baxter Pharmaceutical Solutions, LLC - February 20, 2024

Source: https://www.keypedia.com/records/483/baxter-pharmaceutical-solutions-llc/eb37852c-d304-4aa1-b686-b66af3adb296

> FDA 483 for Baxter Pharmaceutical Solutions, LLC on February 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Pharmaceutical Solutions, LLC
- Inspection Date: 2024-02-20
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Baxter Pharmaceutical Solutions, LLC in Bloomington, IN, was cited for significant deficiencies in aseptic processing, environmental monitoring, and quality control during an FDA inspection. The inspection revealed issues with media fill validation, aseptic technique, visual inspection procedures for sterile products, and data integrity practices. These findings indicate a lack of adequate controls to prevent microbiological contamination and ensure product quality and sterility.

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## Related Officers

- [Laurimer Kuilan-Torres](https://www.keypedia.com/people/laurimer-kuilan-torres/a7f49e33-9d35-4dfe-8bcc-d369d3834ef4)
- [investigator](https://www.keypedia.com/people/ruo-hui-rose-xu/aa9de7e7-5115-4589-b5bf-0d9b87726d79)
- [Yiwei Li](https://www.keypedia.com/people/yiwei-li/e5ea2c24-8e1e-43be-be23-e276b8848cff)

Company: https://www.keypedia.com/companies/baxter-pharmaceutical-solutions-llc/dd8344ef-ad46-49b8-8b39-fb1d8cb518d8

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321