# FDA 483 - FinVector Oy - May 28, 2024

Source: https://www.keypedia.com/records/483/finvector-oy/b1f698cf-2a2f-48d2-99c8-cdacc475988c

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

---

## Details

- Record Type: 483
- Company Name: FinVector Oy
- Inspection Date: 2024-05-28
- Product Type: biologics
- Office Name: Division of Blood Components and Devices
- Summary: An FDA inspection of FinVector Oy's biologics/viral vector facility in Kuopio, Finland, revealed several significant deficiencies. These included inadequate validation of supplier analyses for container/closure systems and raw materials, a lack of robust quality control unit oversight for procedures and reserve sample inspection, and insufficient validation of critical process parameters for cell infection. The firm also lacked proper written procedures for equipment maintenance and material sampling and testing.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/finvector-oy/aedbde8d-a25b-44a7-b6b2-7536a0dad18d)
- [483 - Unknown Date](https://www.keypedia.com/records/483/finvector-oy/c9461ba7-41e6-4aef-a04e-bc9d496b6129)
- [483 - Unknown Date](https://www.keypedia.com/records/483/finvector-oy/ead568f5-ebb6-482f-9e9c-e4d5967d311c)
- [483 - Unknown Date](https://www.keypedia.com/records/483/finvector-oy/6a821dbe-4cfd-47f2-9668-88826378264b)
- [483 - 2024-05-28](https://www.keypedia.com/records/483/finvector-oy/abcb6849-20af-4538-87a5-e1796b468ce9)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917