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

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.