FDA 483 - Granules Pharmaceuticals Inc. - December 15, 2023

Granules Pharmaceuticals Inc. in Chantilly, VA, was inspected and cited for significant deficiencies in quality control, facility maintenance, equipment qualification, and material segregation. The firm failed to properly manage rejected materials, released drug products without adequate sampling, and operated unqualified equipment, indicating a lack of adherence to good manufacturing practices. These issues pose a risk to the identity, strength, quality, and purity of drug products.