# FDA 483 - Seqirus Vaccines Limited - May 26, 2023

Source: https://www.globalkeysolutions.net/records/483/seqirus-vaccines-limited/37190593-ed2a-4ccb-8df8-a04b6562179f

> FDA 483 for Seqirus Vaccines Limited on May 26, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Seqirus Vaccines Limited
- Inspection Date: 2023-05-26
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)
- [Lewis K. Antwi](https://www.globalkeysolutions.net/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)

Company: https://www.globalkeysolutions.net/companies/seqirus-vaccines-limited/6ad0915f-2ffc-46ca-be22-7620c05657c7

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321