FDA 483 - ALI Pharmaceutical Manufacturing LLC - December 01, 2017
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 2cd46e70-9b2a-475f-92d5-516cc6921f0a