The inspection was conducted between 2 March 2026 and 7 March 2026. Following the inspection, the US regulator issued Form 483, noting two observations at the facility.
The company said it will address the observations and respond to the US FDA within the stipulated timeframe. Lupin added that it remains committed to compliance with Current Good Manufacturing Practice (CGMP) standards across all its facilities.
Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
The pharmaceutical company reported a 37.46% surge in consolidated net profit to Rs 1,175.55 crore in Q3 FY26 as against Rs 855.16 crore posted in Q3 FY25. Total revenue from operations jumped 24.26% year-on-year to Rs 7,167.52 crore in the quarter ended 31 December 2025.