Jubilant Life Sciences has been informed by the U.S. Food and Drug Administration (USFDA), in correspondence dated 13 March 2019, received on 21 March 2019 that the inspection from December 10-18, 2018 at the Jubilant Generics API manufacturing facility, in Nanjangud, Mysore, 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 FDA could withhold approval of any pending applications or supplements in which this facility is listed.
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