At another Lupin plant, the company deemed failed quality tests outliers, and retested the samples to get a passing result. In a warning letter to Lupin, the US FDA called the issues “significant violations”. The two facilities are “big meaningful plants for us,” Nilesh Gupta, Lupin managing director, said on 7 November during a call with analysts. Lupin also held products at each phase of production for too long, which can cause quality problems, the agency said. Lupin has about as many as 50 products awaiting US FDA approval that could be affected by the issues.

Source: Mint November 15, 2017 04:41 UTC