Baxter Pharmaceutical Solutions, LLC

FDA 483 - Baxter Pharmaceutical Solutions, LLC

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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.

Company: Baxter Pharmaceutical Solutions, LLC
Product Type: Biologics
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Xiuju Lu (Lead Consumer Safety Officer)

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ID · 18f3a643-f7a3-4880-971e-adfe35384dca