FDA 483 - Intas Pharmaceuticals Limited - August 02, 2019

Intas Pharmaceuticals Limited in Ahmedabad, Gujarat, India, was inspected by the FDA from July 22 to August 2, 2019. The inspection revealed significant deficiencies across multiple areas, including inadequate validation of aseptic and sterilization processes, unsuitable testing methods, failures in cleaning validation, and environmental control issues. These observations indicate a lack of robust quality control and assurance systems for sterile drug product manufacturing.