USFDA inspection update on Jubilant HollisterStier’s Montreal facility
Drug Approval

USFDA inspection update on Jubilant HollisterStier’s Montreal facility

HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures

  • By IPP Bureau | September 30, 2024

Jubilant Pharmova Limited has announced that Jubilant HollisterStier General Partnership (JHSGP) has received a communication from the United States Food and Drug Administration (USFDA), through which the regulatory agency intimated that pursuant to its audit of JHSGP’s contract manufacturing facility (CMO) located at Montreal, Canada in the month of June ’2024, it has determined the inspection classification of the facility as “Official Action Indicated” (OAI).

The said audit was reported by the company on 18th June, 2024. Since then JHSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures. JHSGP is a subsidiary of Jubilant HollisterStier Inc., USA, a step down subsidiary of Jubilant Pharma Ltd., Singapore, which is a wholly owned subsidiary of the company.

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