# FDA 483 - Solvias AG - November 22, 2022

Source: https://www.globalkeysolutions.net/records/483/solvias-ag/d52e4437-b051-4603-9491-065d33b20e4f

> FDA 483 for Solvias AG on November 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Solvias AG
- Inspection Date: 2022-11-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Solvias AG, a control testing laboratory in Kaiseraugst, Switzerland, revealed significant deficiencies in their quality system. Observations included a failure to thoroughly investigate out-of-specification results and equipment malfunctions, as well as inadequate calibration and mapping of stability chambers and sensors. These issues raise concerns about the reliability of testing data for U.S. drug products.

## Related Documents

- [483 - 2023-09-01](https://www.globalkeysolutions.net/records/483/solvias-ag/1cbca27c-d586-41c2-bef3-cb75506fddbe)

## Related Officers

- [Xiaokuang Lai](https://www.globalkeysolutions.net/people/xiaokuang-lai/6c25851d-0954-4f42-8f14-c2e0382e6815)
- [Investigator](https://www.globalkeysolutions.net/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1