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

Source: https://www.keypedia.com/records/483/granules-pharmaceuticals-inc/ff217be2-7175-40cb-a94a-9d59b9094abe

> 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: Baltimore District Office
- Summary: 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.

## Related Documents

- [483 - 2023-12-15](https://www.keypedia.com/records/483/granules-pharmaceuticals-inc/ac2d6df3-5fe0-4df5-8fc5-fcd3805e2087)
- [EIR - 2022-01-28](https://www.keypedia.com/records/eir/granules-pharmaceuticals-inc/67f54236-78b9-4398-93b3-349428010285)
- [483 - 2019-08-21](https://www.keypedia.com/records/483/granules-pharmaceuticals-inc/56ccf589-fc0f-403a-81ea-fef283c58c0d)
- [483 - 2025-06-27](https://www.keypedia.com/records/483/granules-pharmaceuticals-inc/903c5e10-6a83-4038-a7fa-4a6b00d240b1)
- [483 - 2022-07-22](https://www.keypedia.com/records/483/granules-pharmaceuticals-inc/8b164ba2-7c87-4681-bcc0-c7ba8f6d66e7)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa