FDA 483 - ALI Pharmaceutical Manufacturing LLC - October 03, 2022

ALJ Pharmaceutical Manufacturing, LLC in Omaha, NE, a drug substance manufacturer, received a Form 483 with four observations. The inspection revealed significant deficiencies in process validation, microbiological specifications, investigation procedures for deviations and out-of-specification results, and quality unit responsibilities. These issues indicate a lack of scientific soundness and control over manufacturing processes, potentially impacting product quality and purity.