# FDA 483 - FinVector Oy - May 28, 2024

Source: https://www.globalkeysolutions.net/records/483/finvector-oy/abcb6849-20af-4538-87a5-e1796b468ce9

> FDA 483 for FinVector Oy on May 28, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FinVector Oy
- Inspection Date: 2024-05-28
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: FinVector Oy, a biologics/viral vector facility in Kuopio, Finland, was cited with five observations during an FDA inspection. The observations highlight significant deficiencies in quality control, supplier management, equipment maintenance, and process validation. These issues include inadequate validation of supplier test results for primary containers and raw materials, lack of procedures for reserve sample inspection, and insufficient validation of critical process parameters for cell infection.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/finvector-oy/aedbde8d-a25b-44a7-b6b2-7536a0dad18d)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/finvector-oy/ead568f5-ebb6-482f-9e9c-e4d5967d311c)

## Related Officers

- [Lewis K. Antwi](https://www.globalkeysolutions.net/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)
- [Gene D. Arcy](https://www.globalkeysolutions.net/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)

Company: https://www.globalkeysolutions.net/companies/finvector-oy/880a8467-a5a4-431b-b597-7dd6e59b185b

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