# FDA 483 - FinVector Oy - Unknown Date

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.

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- [483 - Unknown Date](https://www.keypedia.com/records/483/finvector-oy/ead568f5-ebb6-482f-9e9c-e4d5967d311c)
- [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

- [Laura Fontan, CSO, Lead Inspector](https://www.keypedia.com/people/laura-fontan-cso-lead-inspector/912362f5-6392-4681-8598-cda541025c45)
- [Jared Greeneaf, CSO, Inspector](https://www.keypedia.com/people/jared-greeneaf-cso-inspector/45708f46-848e-46af-8e5c-f4b8409368ab)

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