# FDA 483 - Seqirus Pty Ltd - June 06, 2025

Source: https://www.keypedia.com/records/483/seqirus-pty-ltd/96c86fab-f499-45c0-bee1-19ea35d6462a

> FDA 483 for Seqirus Pty Ltd on June 06, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Seqirus Pty Ltd
- Inspection Date: 2025-06-06
- Product Type: biologics
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Documents

- [483 - 2025-06-06](https://www.keypedia.com/records/483/seqirus-pty-ltd/8c249df6-cd14-464f-bc25-0227d7d5a7f9)

## Related Officers

- [Travis S. Bradley](https://www.keypedia.com/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)
- [Peng Zhou](https://www.keypedia.com/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)

Company: https://www.keypedia.com/companies/seqirus-pty-ltd/673f8bd1-d8ea-4125-a3cf-a83827b17359

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8