FDA 483 - Akom Pharmaceuticals, Inc. - April 08, 2022

An FDA inspection of Akorn, Inc. in Decatur, IL, a sterile drug manufacturer, revealed significant deficiencies across its quality systems. Observations included failures to follow procedures designed to prevent microbiological contamination, inadequate investigations into unexplained discrepancies and product failures, and a lack of written procedures for critical production and process controls. These issues suggest a systemic breakdown in maintaining product quality and purity.