FDA 483 - Labor Augsburg MVZ GmbH - May 09, 2025

Between May 5 and May 9, 2025, the U.S. Food and Drug Administration (FDA) conducted an inspection of Labor Augsburg MVZ GmbH, a biopharmaceutical analytical facility located in Augsburg, Germany. The inspection focused on the integrity of clinical trial data, specifically regarding the measurement of sCTx. The FDA investigator identified two significant procedural failures. First, the laboratory failed to follow its own quality control protocols; on several dates between 2021 and 2022, the facility continued with study sample analysis despite quality control samples showing a bias exceeding the 20% limit. Second, the facility did not retain the original electronic source data generated by their analytical instruments, which are essential for verifying the derived concentration results. These findings were issued under Section 704(b) of the FD&C Act. While this form represents inspectional observations rather than a final compliance determination, the facility is required to address these issues. The company should respond to the FDA with a detailed plan for corrective actions to improve data retention and ensure strict adherence to quality acceptance criteria in future clinical studies.