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

An FDA inspection of Granules Pharmaceuticals Inc. in Chantilly, VA, revealed a significant data integrity concern related to computer system controls. The firm was cited for not ensuring that changes to master production and control records are instituted only by authorized personnel. This issue stems from the use of shared login credentials and the ability of users to modify system date and time settings on laboratory computers.