FDA 483 - Baxter Pharmaceutical Solutions, LLC - November 10, 2021

An FDA inspection of Baxter Pharmaceuticals Solutions, LLC in Bloomington, IN, revealed significant deficiencies in quality control and facility maintenance. Observations included a failure to thoroughly review unexplained discrepancies in product rejection rates, persistent insect infestation in classified manufacturing areas despite multiple corrective actions, and a lack of adequate authority for the Quality Control unit to fully investigate errors due to restricted access to critical production areas. These issues suggest a systemic breakdown in quality oversight and environmental control.