Akom Pharmaceuticals, Inc. – FDA 483, Apr 26, 2017

An FDA inspection of Akorn, Inc. in Decatur, IL, revealed significant deficiencies in their sterile drug manufacturing operations. Observations included a failure of the quality control unit to follow written procedures, issues with equipment design leading to particle contamination on a vial staging mechanism, and inadequate validation of sterilization processes for sterile drug products. These findings indicate serious concerns regarding the firm's control over aseptic processing and product quality.