FDA 483 - Ophtapharm AG - February 28, 2020

An FDA inspection of Akorn AG in Hettlingen, Switzerland, revealed significant deficiencies in quality control and manufacturing processes. Observations included inadequate training for supervisory personnel, failure to properly manage changes to written procedures, and a lack of yield determination and investigation into process variations. These issues indicate a lack of robust quality systems impacting drug product safety, identity, strength, quality, and purity.