FDA 483 - Lupin Limited (Biotech Division) - October 14, 2022

Lupin Limited (Biotech Division) in Pune, India, was inspected by the FDA from October 3-14, 2022, and received 18 observations. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, quality control, and facility maintenance for drug substance and drug product manufacturing. These issues indicate a lack of adequate controls to prevent contamination and ensure product quality and purity.