# FDA 483 - FinVector Oy - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/finvector-oy/aedbde8d-a25b-44a7-b6b2-7536a0dad18d

> 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: FinVector Oy, a drug substance and drug product manufacturer in Kuopio, Finland, was inspected and found to have significant deficiencies across its quality system. Key issues include inadequate Quality Assurance oversight, poorly defined quality procedures, inadequately qualified quality control assays, and deficiencies in aseptic operations, cleaning, and disinfection. The inspection also revealed problems with shipping validation, lack of procedures for commercial lot manufacturing, insufficient employee training, and inadequate management of GMP data.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/finvector-oy/ead568f5-ebb6-482f-9e9c-e4d5967d311c)
- [483 - 2024-05-28](https://www.globalkeysolutions.net/records/483/finvector-oy/abcb6849-20af-4538-87a5-e1796b468ce9)

## Related Officers

- [Anurag Sharma, Ph.D., Staff Fellow](https://www.globalkeysolutions.net/people/anurag-sharma-phd-staff-fellow/0852e654-80ac-4d83-a925-ee3841ea930a)
- [Zhi He, Ph.D., Biologist](https://www.globalkeysolutions.net/people/zhi-he-phd-biologist/e85d4b47-bf8c-4940-bc36-96c257c09b3c)
- [Laura Fortun, CSO](https://www.globalkeysolutions.net/people/laura-fortun-cso/66af427d-5dc3-4270-97b5-376dd1b55cf7)
- [Ramjee Vatsan, Ph.D., Biologist Team Lead](https://www.globalkeysolutions.net/people/ramjee-vatsan-phd-biologist-team-lead/82462453-0e39-49bd-867d-3b5f73d53535)
- [investigator](https://www.globalkeysolutions.net/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)

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