It is indicative of the cGMP status at the facility since receiving the warning letter in 2013
Jubilant Life Sciences announced that its subsidiary, Jubilant HollisterStier has been informed by the US Food and Drug Administration (US FDA) that its pharmaceutical sterile manufacturing facility in Spokane, Washington (US) has been upgraded to the status of Voluntary Action Indicated (VAI).
The Spokane site’s latest Establishment Inspection Report (EIR) indicates the inspections in April 2014 and December 2014 have been successfully concluded. This upgradation by the US FDA from Official Action Indicated (OAI) to VAI is indicative of the cGMP status at the facility since receiving the warning letter in 2013.
Commenting on the development, Shyam S Bhartia, Chairman and Hari S Bhartia, Co-Chairman and Managing Director, Jubilant Life Sciences said, “Jubilant remains committed to continuous improvements to maintain compliance at all its pharmaceutical manufacturing facilities across the globe. We consider this development as another step towards building a reliable and sustainable pharmaceutical business”.
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