# FinVector Oy – FDA 483

Source: https://www.keypedia.com/records/483/finvector-oy/6a821dbe-4cfd-47f2-9668-88826378264b

> 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: An FDA inspection of Fin Vector Oy in Kuopio, Finland, a drug substance and drug product manufacturer, revealed multiple significant deficiencies. Observations included inadequate qualified personnel, poor equipment maintenance leading to breakdowns, and a quality system allowing for planned deviations. Additionally, issues with contamination prevention procedures, inadequate cleaning equipment maintenance, and incomplete validation for labeling and packaging equipment were noted.

## Related Documents

- [483 - 2026-03-04](https://www.keypedia.com/records/483/finvector-oy/fd6ac7fb-6403-41ac-8e7d-fef0a90f421b) — date: March 4, 2026
- [483 - 2024-05-28](https://www.keypedia.com/records/483/finvector-oy/b1f698cf-2a2f-48d2-99c8-cdacc475988c) — date: May 28, 2024
- [483](https://www.keypedia.com/records/483/finvector-oy/aedbde8d-a25b-44a7-b6b2-7536a0dad18d)

## Related Officers

- [Jared Greeneaf, CSO, Inspector](https://www.keypedia.com/people/jared-greeneaf-cso-inspector/45708f46-848e-46af-8e5c-f4b8409368ab)
- [investigator](https://www.keypedia.com/people/laura-fontan/b27b02a3-9ab1-49df-b2bc-ee936b69d76a)
- [Jared D. Greenleaf](https://www.keypedia.com/people/jared-d-greenleaf/189acc23-624a-4f30-b1ca-bf92aef1de0a)

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