The U.S. Food and Drug Administration (FDA) has flagged four issues at generic pharmaceutical giant Lupin’s biotech manufacturing facility located in Pune, India.
These observations arose from a product-specific pre-approval inspection conducted by the U.S. FDA at the Pune site between September 8 and 19. Following the inspection, Lupin acknowledged the four observations and confirmed in a recent filing that it plans to address them and submit a comprehensive response to the U.S. FDA within the designated period.