# FDA 483 - Granules Pharmaceuticals Inc. - April 03, 2026

Source: https://www.keypedia.com/records/483/granules-pharmaceuticals-inc/d8b4fccb-5ec0-4d32-b070-267fbae547e0

> FDA 483 for Granules Pharmaceuticals Inc. on April 03, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Granules Pharmaceuticals Inc.
- Inspection Date: 2026-04-03
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Granules Pharmaceuticals Inc. in Chantilly, VA, revealed significant deficiencies in quality control and facility maintenance. The firm failed to adequately investigate recurring stability failures and uncharacterized impurities, and did not consistently adhere to its written stability testing program. Additionally, issues were noted with incomplete batch production records and critical HVAC equipment failures leading to product contamination.

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## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)
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Company: https://www.keypedia.com/companies/granules-pharmaceuticals-inc/fa93bf3f-822e-47be-9e47-59b1c5446629

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