FDA 483 - Indiana Chem-Port - August 07, 2021

Indiana Chem-Port, an Active Pharmaceutical Ingredient manufacturer in Vadodara, India, was inspected by the FDA from August 2-7, 2021. The inspection revealed significant deficiencies across its manufacturing and quality control operations, including a lack of process validation, inadequate quality unit oversight, and poor data integrity controls. These issues indicate a systemic failure to ensure product quality and purity.