Solvias AGSeptember 1, 2023

FDA 483 - Solvias AG - September 01, 2023

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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.

Company: Solvias AG
Inspection Date: September 1, 2023
Product Type: Drugs
Office: International Compliance Team
Person: Kara A. Scheibner (issuing_officer)

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ID · 1cbca27c-d586-41c2-bef3-cb75506fddbe