# FDA 483 - FinVector Oy - Unknown Date

Source: https://www.keypedia.com/records/483/finvector-oy/c9461ba7-41e6-4aef-a04e-bc9d496b6129

> FDA 483 for FinVector Oy on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FinVector Oy
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: FinVector Oy, a drug substance and drug product manufacturer in Kuopio, Finland, was inspected by the FDA in January 2020. The inspection revealed significant deficiencies across its pharmaceutical quality system, including inadequate QA oversight, poorly defined quality procedures, unqualified assays, and issues with aseptic operations, cleaning, disinfection, and data management. These findings indicate a lack of robust controls and validation, potentially impacting product quality and safety.

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- [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)
- [483 - 2024-05-28](https://www.keypedia.com/records/483/finvector-oy/b1f698cf-2a2f-48d2-99c8-cdacc475988c)

## Related Officers

- [Bradley Dworak](https://www.keypedia.com/people/bradley-dworak/b78fa75d-139f-4e7d-b30e-808346d60fc5)
- [investigator](https://www.keypedia.com/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)
- [Ranjay Tatsat, Ph.D.](https://www.keypedia.com/people/ranjay-tatsat-phd/2c0d17b2-3ee3-4061-b371-bb2622cc8fd6)
- [Leah Fontana, CSO](https://www.keypedia.com/people/leah-fontana-cso/93551a14-3feb-484f-84b8-1f1dd4a4b2af)
- [Anurag Sharma, Ph.D., Staff Fellow](https://www.keypedia.com/people/anurag-sharma-phd-staff-fellow/0852e654-80ac-4d83-a925-ee3841ea930a)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4