Labor Augsburg MVZ GmbHMay 9, 2025

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

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Record Details

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.

Company: Labor Augsburg MVZ GmbH
Inspection Date: May 9, 2025
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Melkamu Getie-Kebtie

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ID · 4c43b8f2-45ea-4873-a2db-55742a67099d