U.S. FDA issues 4 observations to Lupin’s Pune Biotech facility

The U.S. Food and Drug Administration has issued four observations to generic drugmaker Lupin’s biotech facility in Pune.

The U.S. FDA conducted a product-specific pre-approval inspection at the company’s Pune biotech facility from September 8-19. The inspection closed with four observations. “We will address the observations and respond to the U.S. FDA within the stipulated timeframe,” Lupin said in a filing on Saturday.