FDA 483 - Novo Nordisk A/S - 25a-B - November 07, 2023

An FDA inspection of Novo Nordisk A/S in Hillerod, Denmark, revealed significant deficiencies in preventing microbiological contamination of sterile drug products. The firm also failed to establish adequate control procedures to validate manufacturing processes, leading to variability and high false rejection rates in visual inspection. These observations indicate a need for improved aseptic processing controls and process validation.