FDA 483 - Wyeth Pharmaceutical Division of Wyeth Holdings LLC - November 10, 2023

An FDA inspection of Wyeth Pharmaceutical Division of Wyeth Holdings LLC in Sanford, NC, from November 6 to November 10, 2023, identified a significant quality control issue. The firm failed to perform a required test on incoming starting material used in the manufacturing of Fidanacogene Elaparvovec. This indicates a potential lapse in ensuring the quality and safety of materials entering the production process.