Jubilant Pharmova arm gets OAI status from USFDA for Montreal facility
The US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.
Noida: Jubilant HollisterStier General Partnership (JHSGP), a wholly owned subsidiary of Jubilant Pharmova Limited has announced that it received a communication from the US Food and Drug Administration (USFDA) through which the latter intimated that pursuant to its February 2023 audit of the Contract Manufacturing (CMO) facility at Montreal Canada, the US FDA has determined inspection classification of the facility as “Official Action Indicated”(OAI).
Official Action Indicated means regulatory and/or administrative actions will be recommended.
The US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.
"The Company is engaging closely with the USFDA and is committed to address the observations within the stipulated time," the company stated.
