FDA 483 - Novo Nordisk A/S - 25a-B - January 17, 2020

Novo Nordisk A/S, a control testing laboratory in Hillerod, Denmark, was cited for failing to conduct thorough investigations into unexplained discrepancies. The firm did not adequately investigate unknown peaks detected multiple times during HPLC analysis, leading to an insufficient root cause determination. This indicates a significant lapse in their quality control and deviation management systems.