Jubilant Pharma Gets USFDA VAI Classification for Roorkee Unit
Apr 17, 2024 17:07
Jubilant Pharma's Roorkee unit receives a Voluntary Action Indicated (VAI) classification from the USFDA, indicating acceptable compliance with cGMP.
New Delhi, Apr 17 (PTI) Jubilant Pharma on Wednesday said the US health regulator has decided that the inspection classification of its subsidiary's Roorkee-based plant is voluntary action indicated (VAI).
Jubilant Pharmova, a wholly-owned subsidiary of the company, has received a communication from the US Food and Drug Administration (USFDA) that the facility has been classified as VAI pursuant to inspection from January 25 to February 2, 2024, it said in a regulatory filing.
As per the USFDA, a VAI inspection classification indicates that although investigators found and documented objectionable conditions during the inspection, FDA will not take or recommend regulatory or enforcement action because the objectionable conditions do not meet the threshold for action at this time.
"Based on this inspection and the USFDA VAI classification, the facility is considered to be in acceptable state of compliance with regard to current good manufacturing practices (cGMP)," it added.
With this, the FDA has concluded that this inspection is closed, Jubilant Pharma said.
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