FDA 483 - ALI Pharmaceutical Manufacturing LLC - May 03, 2024

An FDA inspection of ALI Pharmaceutical Manufacturing, LLC in Omaha, NE, a human drug substance manufacturer, revealed significant deficiencies in laboratory controls. The firm was cited for invalidating out-of-specification (OOS) results without scientific justification and for inadequate investigations into critical deviations and batch failures, including a repeat observation. These issues indicate a lack of robust quality control and investigation processes.