FDA 483 - Granules Pharmaceuticals Inc. - July 22, 2022

Granules Pharmaceuticals Inc. in Chantilly, VA, was inspected and cited for significant deficiencies in its drug manufacturing operations. The inspection revealed failures in quality control unit procedures, non-adherence to production and process control procedures, inadequately designed equipment, and insufficient investigations into major incidents. Additionally, the firm lacked proper procedures to prevent objectionable microorganisms and detailed sanitation methods.