FDA 483 - Granules Pharmaceuticals Inc. - June 27, 2025

An FDA inspection of Granules Pharmaceuticals Inc. in Chantilly, VA, revealed a significant concern regarding data integrity and control over computer systems. The firm's QC laboratory personnel were found to be using shared login credentials for analytical testing systems, preventing individual accountability. Additionally, users had the ability to alter system date and time settings on laboratory computers, indicating a lack of appropriate controls.