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

Source: https://www.globalkeysolutions.net/records/483/granules-pharmaceuticals-inc/903c5e10-6a83-4038-a7fa-4a6b00d240b1

> FDA 483 for Granules Pharmaceuticals Inc. on June 27, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Granules Pharmaceuticals Inc.
- Inspection Date: 2025-06-27
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: 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.

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## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.globalkeysolutions.net/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)
- [Kara J. Wright](https://www.globalkeysolutions.net/people/kara-j-wright/d12b6a4f-9710-4811-b1b2-5ff5f9342155)

Company: https://www.globalkeysolutions.net/companies/granules-pharmaceuticals-inc/fa93bf3f-822e-47be-9e47-59b1c5446629

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64