FDA 483 - Granules Pharmaceuticals Inc. - June 25, 2021

Granules Pharmaceuticals Inc. in Chantilly, VA, was inspected by the FDA from June 21-25, 2021, regarding preapproval coverage for Dofetilide Capsules. The inspection revealed significant deficiencies in quality control unit procedures, including inadequate qualification of capsule storage facilities and lack of timely review for logbooks. Additionally, the firm failed to maintain adequate written procedures and documentation for cleaning and maintenance, with unlabeled cleaning agents observed.