# FDA 483 - Solvias AG - September 01, 2023

Source: https://www.globalkeysolutions.net/records/483/solvias-ag/1cbca27c-d586-41c2-bef3-cb75506fddbe

> FDA 483 for Solvias AG on September 01, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Solvias AG
- Inspection Date: 2023-09-01
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: During an inspection, Solvias AG, a Contract Research Organization in Kaiseraugst, Switzerland, was cited for issues related to data integrity in method validation. The firm rejected and repeated precision and accuracy data without proper justification. Specifically, a claimed dilution error used to justify retesting was not documented in the sample preparation records.

## Related Documents

- [483 - 2022-11-22](https://www.globalkeysolutions.net/records/483/solvias-ag/d52e4437-b051-4603-9491-065d33b20e4f)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/kara-a-scheibner/63643a3f-4a8e-4dcc-8f1a-6fcf98519aad)

Company: https://www.globalkeysolutions.net/companies/solvias-ag/3b9382f0-b4d1-46ef-885f-0ccd44ab4d1a

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321