FDA 483 - NOVAVAX CZ - July 18, 2023

An FDA inspection of Novavax CZ in Jevany, CZ, revealed several significant deficiencies in their manufacturing processes. Observations included inadequate data in validation reports, lack of support for reference standards, and unvalidated holding times for process intermediates. The firm also faced issues with disinfectant efficacy studies, untimely corrective actions for recurring integrity failures, and deficient product handling procedures.