483
Solvias AGSolvias AG – FDA 483, Sep 1, 2023
Record Details
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.
View Company Profile
ID · 1cbca27c-d586-41c2-bef3-cb75506fddbe
Other documents for Solvias AG
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.