FDA 483 - Hikma Farmaceutica, (Portugal) S.A. - April 21, 2023

An FDA inspection of Hikma Farmaceutica, (Portugal) S.A., a sterile drug manufacturer, revealed significant deficiencies in their quality control and manufacturing processes. Observations included inadequate aseptic processing validation, failures in thoroughly investigating discrepancies and customer complaints, and issues with laboratory controls and stability testing. These findings indicate a lack of robust systems to ensure the quality and purity of sterile drug products.