FDA 483 - Seqirus Pty Ltd - June 06, 2025

From May 29 to June 6, 2025, the U.S. Food and Drug Administration (FDA) conducted an inspection of the Seqirus Pty Ltd vaccine manufacturing facility in Parkville, Australia. The inspection focused on the production of the Afluria bulk vaccine and identified several significant lapses in quality control and facility maintenance under the regulatory framework of the Federal Food, Drug, and Cosmetic Act.

A major violation involved the persistent presence of mold (Fusarium oxysporum) within production areas across three consecutive manufacturing campaigns from 2023 to 2026. The FDA noted that the company failed to thoroughly investigate these occurrences or identify a root cause, and many instances were not even documented as official deviations. Furthermore, the physical facility was found to be inadequately maintained, with visible gaps in a storage building that exposed raw materials and components to the outside environment.

Additional concerns were raised regarding data security and record-keeping. The firm had not completed necessary risk assessments for digital data integrity first identified in 2021. Furthermore, critical testing equipment lacked unique user logins, and historical data was not properly reconciled against batch records. While these findings do not represent a final agency determination, Seqirus is required to respond to the FDA by either contesting the observations or submitting a detailed plan for corrective actions to address these deficiencies and ensure future compliance.