# FDA 483 - FinVector Oy - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/finvector-oy/ead568f5-ebb6-482f-9e9c-e4d5967d311c

> 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: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Fin Vector Oy in Kuopio, Finland, a drug substance and drug product manufacturer, revealed six observations. These included inadequate qualified personnel, poorly maintained manufacturing equipment leading to breakdowns, a quality system allowing planned deviations for equipment issues, and insufficient procedures to prevent contamination. Additionally, cleaning equipment for drug product components was not adequately maintained, and validation documentation for labeling and packaging equipment was incomplete.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/finvector-oy/aedbde8d-a25b-44a7-b6b2-7536a0dad18d)
- [483 - 2024-05-28](https://www.globalkeysolutions.net/records/483/finvector-oy/abcb6849-20af-4538-87a5-e1796b468ce9)

## Related Officers

- [Jared D. Greenleaf](https://www.globalkeysolutions.net/people/jared-d-greenleaf/189acc23-624a-4f30-b1ca-bf92aef1de0a)
- [investigator](https://www.globalkeysolutions.net/people/laura-fontan/b27b02a3-9ab1-49df-b2bc-ee936b69d76a)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd