FDA 483 - Allergan Pharmaceuticals Ireland - December 17, 2019

An FDA inspection of Allergan Pharmaceuticals Ireland in Westport, County Mayo, Ireland, identified significant deficiencies in quality control and manufacturing processes. Observations included inadequate visual inspection and AQL programs for injectable products, failure to properly sanitize a fill line after a repair, and issues with equipment calibration and utility qualification. These findings indicate a need for improved controls to ensure drug product quality and purity.