FDA 483 - Allergan Sales, LLC - October 08, 2015

An FDA inspection of Alcon Sales, LLC in Waco, TX, revealed significant deficiencies in their manufacturing processes for human drug products. The observations included inadequate stability programs, scientifically unsound laboratory controls, and failures in preventing microbiological contamination. Additionally, issues with personnel gowning and environmental monitoring in aseptic processing areas were noted, raising concerns about product quality and sterility.