FDA 483 - Mankind Pharma Limited - March 25, 2025

Mankind Pharma Limited in Paonta Sahib, India, was inspected by the FDA, resulting in three observations. The inspection revealed deficiencies in equipment cleaning and maintenance procedures, inadequate equipment design and operational procedures for decontamination, and scientifically unsound sampling plans for stability studies. These issues indicate a lack of robust controls to ensure drug product quality and purity.