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

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.