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

The U.S. Food and Drug Administration has issued 4 observations to generic drugmaker Lupin’s biotech installation successful Pune.

The U.S. FDA conducted a product-specific pre-approval inspection astatine the company’s Pune biotech installation from September 8-19. The inspection closed with 4 observations. “We volition code the observations and respond to the U.S. FDA wrong the stipulated timeframe,” Lupin said successful a filing connected Saturday.