USFDA recommends regulatory action after Jubilant's Roorkee plant inspection

The US Food and Drug Administration (USFDA) has recommended a regulatory or administrative action after the inspection of the Roorkee manufacturing facility of Jubilant Life Sciences, according to a regulatory filing.

The FDA has classified the inspection of the Roorkee plant as ‘Official Action Indicated (OAI)’, which means approvals of pending applications or supplements from this site maybe withheld, the company said in a stock exchange filing. According to the FDA, ‘OAI’ means regulatory and/or administrative actions will be recommended against a facility after an inspection.

In response to the USFDA inspection conducted at the Roorkee facility of solid dosage formulations during August 2018, “the agency has informed to classify the inspection as OAI and that approvals of pending applications or supplements from this site maybe withheld,” Jubilant Life said. However, this will not have any impact on the existing revenues from operations from this facility, it added. “We believe that this letter has been issued as part of USFDA initiative to respond to the company within 90 days of the inspection, regarding the status,” it said.

As per the guidelines, the company can engage within 40 days to get the agency’s decision downgraded from classifying as OAI, it added. The company “is in the process of sending further update of its corrective actions and remains hopeful of a positive outcome,” it said.