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

The US Food and Drug Administration has issued four observations for biotech facility of generic drug manufacturer Lupine in Pune.

The US FDA conducted a product-specific pre-infinite inspection in the company’s Pune Biotech facility from 8-19 September. The inspection closed with four comments. Lupine said in a filing on Saturday, “We will address the comments and respond to the US FDA within the stipulated time.”