Granules India announced that its wholly owned foreign subsidiary, Granules Pharmaceuticals, Inc. has received a communication from the US FDA indicating the inspection classification as Voluntary Action Indicated. (VAI).
Previously, USFDA issued 6 observations under Form 483 on inspection of its facility located at Chantilly, Virginia, USA.
The VAI inspection classification indicates that the US FDA will not take or recommend regulatory or enforcement action because the observations do not meet the threshold for action at this time.
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