FDA 483 - Intas Pharmaceuticals Limited - June 08, 2018

Intas Pharmaceuticals Limited in Ahmedabad, India, a sterile drug manufacturer, received a Form FDA 483 with two observations. The inspection revealed deficiencies in the environmental monitoring system for sterile drug processing areas, including issues with barrier system studies, media fills, and sterilization process validation. Additionally, the firm failed to thoroughly investigate unexplained discrepancies and equipment failures, as evidenced by several inadequate deviation reports.