FDA 483 - Xellia Pharmaceuticals USA LLC - February 07, 2022

An FDA inspection of Xellia Pharmaceuticals USA LLC in Bedford, OH, a manufacturer of sterile drug products, revealed a significant lapse in quality control unit procedures. The firm failed to submit a field alert report within the required three-day timeframe following notification of an out-of-specification stability result for a distributed batch of Vancomycin Hydrochloride for Injection USP. This delay indicates a failure to adhere to established internal procedures for critical product quality issues.