FDA 483 - Novartis Gene Therapies Inc. - January 26, 2024

Novartis Gene Therapies Inc. in Durham, NC, was inspected and cited for two observations related to its licensed biological drug product manufacturing. The firm failed to report a biological product deviation within the required 45-day timeframe for ZOLGENSMA Drug Product. Additionally, laboratory investigations into out-of-specification results for ZOLGENSMA Drug Substance were not adequately extended to other associated drug product and drug substance lots.