FDA 483 - ALI Pharmaceutical Manufacturing LLC - December 01, 2017

An FDA inspection of American Laboratories Inc. in Omaha, NE, revealed significant deficiencies in their active pharmaceutical ingredient operations. Observations included discarding analytical data to mask process variation, inadequate procedures for handling returned opened products, and inaccuracies in complaint investigations. The inspection also noted issues with the firm's deviation and discrepancy investigation process, potentially leading to undocumented deviations.