FDA 483 - Solvias AG - November 22, 2022

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.