FDA 483 - NOVAVAX CZ - July 18, 2023

An FDA inspection of Novavax CZ in Jevany, CZ, revealed significant deficiencies in data validation, process validation, and quality control. Observations included inadequate data to support validation reports, lack of data for potency determination, unvalidated holding times for process intermediates, and failed disinfectant efficacy studies. The firm also failed to implement timely corrective actions for recurring integrity failures and had deficient procedures for product handling.