# FDA 483 - Baxter Pharmaceutical Solutions, LLC - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/baxter-pharmaceutical-solutions-llc/18f3a643-f7a3-4880-971e-adfe35384dca

> FDA 483 for Baxter Pharmaceutical Solutions, LLC on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Pharmaceutical Solutions, LLC
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Baxter Pharmaceutical Solutions, LLC in Bloomington, Indiana, from July 22-26, 2024, identified a significant issue regarding adherence to established manufacturing procedures. Specifically, an instrument overdue for calibration was improperly released and used for manufacturing, contrary to the firm's own standard operating procedures. This indicates a lapse in quality control and procedural compliance.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/baxter-pharmaceutical-solutions-llc/c2258424-7ec3-4182-846d-ce66b310826f)
- [483 - 2021-11-10](https://www.globalkeysolutions.net/records/483/baxter-pharmaceutical-solutions-llc/e58a0478-5a31-4b0c-bf8f-43a2a2cd7673)
- [483 - 2024-02-20](https://www.globalkeysolutions.net/records/483/baxter-pharmaceutical-solutions-llc/eb37852c-d304-4aa1-b686-b66af3adb296)

## Related Officers

- [Lead Consumer Safety Officer](https://www.globalkeysolutions.net/people/xiuju-lu/90517f8a-e5ac-44a9-b2a2-3358e114754f)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd