USFDA classifies Jubilant Draximage Montreal facility as VAI

Noida: Jubilant Pharmova Limited's wholly owned subsidiary Jubilant Pharma Limited, has announced that its subsidiary Jubilant Draximage Inc. ('JDI') has received a communication from the U.S. Food and Drug Administration (USFDA) through which the regulatory agency intimated that pursuant to its audit of JDI’s Radiopharmaceutical manufacturing facility at Montreal, Canada in the month of April, 2024, it has determined the inspection classification of the facility as “Voluntary Action Indicated”.

Voluntary action indicated (VAI), means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

Medical Dialogues team had earlier reported that the USFDA had concluded the audit of the Jubilant HollisterStier General Partnership ("JHSGP")’s contract manufacturing facility located in Montreal, Canada.

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Jubilant Pharma Limited, a Company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Pharmova Limited, is an integrated global pharmaceutical company engaged in manufacturing and supply of Radiopharmaceuticals with a network of 46 radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products and Solid Dosage Formulations through five manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies.

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