FDA 483 - Seqirus Pty Ltd - June 06, 2025

An FDA inspection of Seqirus Pty Ltd in Parkville, Australia, revealed significant deficiencies in their vaccine manufacturing operations. Observations included inadequate investigations into persistent fungal contamination in drug substance production, structural issues with a building used for component storage, and critical data integrity and user access control failures for manufacturing equipment. These findings indicate a need for comprehensive corrective actions to ensure product quality and data reliability.