FDA 483 - Seqirus Vaccines Limited - May 26, 2023

Seqirus Vaccines Limited, a vaccine manufacturer in Liverpool, United Kingdom, was cited for two observations during an FDA inspection. The firm failed to conduct investigations into unexplained discrepancies related to calibration data for Fluad vaccine testing, impacting product shipped to the US. Additionally, the inspection revealed a lack of effective corrective actions for ongoing trends of issues observed during monovalent bulk drug substance testing, stemming from an external supplier and previously cited in a 2017 FDA 483.