FDA 483 - Xttrium Laboratories, Inc. - June 18, 2025

Xtrium Laboratories, Inc., an API and Finished Product Drug Manufacturer in Mount Prospect, IL, was cited for significant deficiencies across its quality control, data integrity, and record-keeping practices. The inspection revealed issues with unqualified equipment, undocumented analyses, inadequate computer system controls, and a failure to investigate discrepancies, all of which compromise the reliability and integrity of their analytical data and product quality. These findings indicate a systemic breakdown in adherence to established procedures and regulatory requirements.