The USFDA also stated that the facility might be subject to a cGMP regulatory or enforcement action based on this inspection
Jubilant Life Sciences has said it has been cautioned by the US health regulator that its Nanjangud facility in Mysuru may be subject to regulatory action and that the USFDA may withhold approval of any pending applications or supplements in which this facility is listed.
Jubilant Life Sciences in a regulatory filing said it has been informed by the US Food and Drug Administration (USFDA) that inspection from December 10-18, 2018 at the Jubilant Generics API manufacturing facility, in Nanjangud, Mysuru, has been classified as ‘Official Action Indicated’ (OAI). The USFDA also stated that the facility might be subject to a cGMP regulatory or enforcement action based on this inspection, and that USFDA could withhold approval of any pending applications or supplements in which this facility is listed, the filing added.
The company also said that the USFDA’s announcement will not have any impact on the existing revenues from operations of this facility. “We believe that this letter has been issued as part of a USFDA initiative to respond to the company within 90 days of the inspection, regarding the facility’s status. As per the agency’s internal procedures, the company can engage with the agency within 40 days to seek to get the decision downgraded from the OAI classification,” the company said.
Jubilant said, it is in the process of sending a further update to USFDA of its corrective actions regarding the agency’s inspectional observations from December 2018.