FDA 483 - Intas Pharmaceuticals Ltd. - February 14, 2025

Intas Pharmaceuticals Limited received an FDA Form 483 citing significant deficiencies in its aseptic manufacturing processes, quality unit oversight, and facility maintenance. Repeat observations from previous inspections highlight persistent issues with microbial contamination prevention, inadequate environmental monitoring, and a lack of adherence to established procedures, indicating a systemic failure to ensure drug product quality and purity.