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

During an inspection of Labor Augsburg MVZ GmbH's biopharmaceutical analytical facility in Augsburg, FDA investigators observed two significant issues. The firm failed to adhere to established acceptance criteria for quality control samples prior to analyzing study subject samples on multiple occasions. Additionally, the firm did not retain electronic source data for sample analysis, raising concerns about data integrity.