Granules Pharmaceuticals Inc.June 27, 2025

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

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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.

Company: Granules Pharmaceuticals Inc.
Inspection Date: June 27, 2025
Product Type: Drugs
Office: Baltimore District Office
People: David A. Oluwo (Pharmacy Intern/Certified Pharmacy Technician)
Kara J. Wright

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ID · ff217be2-7175-40cb-a94a-9d59b9094abe