FDA 483 - Grant Industries, Inc. - June 16, 2025

Grant Industries, Inc. in Elmwood Park, NJ, a drug manufacturer, was inspected and cited for significant deficiencies across its quality control, production, laboratory, and training systems. Key issues include inadequate process and equipment validation, insufficient stability programs, poor computer system controls leading to data integrity concerns, and a lack of proper testing for raw materials like glycerin. These observations indicate a systemic failure to ensure drug product quality, purity, and strength.