FDA 483 - Xttrium Laboratories, Inc. - March 08, 2024

An FDA inspection of Xtrium Laboratories, Inc. in Mount Prospect, IL, a drug manufacturer, revealed significant deficiencies across multiple areas of its operations. The firm was cited for critical issues including inadequate quality unit oversight of GMP documents, incomplete laboratory records, insanitary facility conditions, and a lack of established hold time studies for drug products. Further concerns involved uncontrolled issuance of manufacturing documents, insufficient computer system controls, and inadequate physical separation between production lines, posing risks of mix-ups and cross-contamination.