FDA 483 - Seqirus Vaccines Limited - May 26, 2023

An FDA inspection of Seqirus Vaccines Limited in Liverpool, UK, revealed significant deficiencies in quality control and investigation processes for their Fluad influenza vaccine. The firm failed to investigate unexplained discrepancies related to calibration data and lacked effective corrective actions for ongoing trends of quality issues in monovalent bulk drug substance. These findings suggest a concerning lapse in ensuring product quality and compliance with manufacturing standards.