FDA 483 - Baxter Healthcare Corporation - September 29, 2025

This FDA Form 483 details significant deficiencies at Baxter Healthcare Corporation in Cleveland, MS, related to manufacturing and quality control. Observations include inadequate investigation of product contamination, unsound laboratory controls for sampling and testing, insufficient data backup, poor equipment maintenance leading to rust contamination, and structural issues in a cleanroom. These issues indicate a lack of robust quality systems that could impact drug product safety and purity.