FDA 483 - Novo Nordisk A/S - May 04, 2023

An FDA inspection of Novo Nordisk A/S in Kalundborg, Denmark, revealed significant deficiencies in contamination control, investigation of discrepancies, and complaint handling. The firm experienced multiple mold and bacterial recoveries in manufacturing areas, coupled with inadequate environmental monitoring and disinfection procedures. Additionally, investigations into product deviations and customer complaints were found to be insufficient, indicating a need for improved quality control and robust procedural adherence.