A facility of Granules India subsidiary in the U.S., which received five observations in December from the U.S Food and Drug Administration post inspection, has since been issued a voluntary action indicated (VAI) classification by the regulator.
The VAI inspection classification indicates the U.S. FDA will not take or recommend regulatory or enforcement action because the observations do not meet the threshold for action at this time, the drugmaker said in a filing on Wednesday. Shares of the company rose 2% to close at ₹453.90 apiece on the BSE.
The facility of the subsidiary, Granules Pharmaceuticals Inc. (GPI), is located in Chantilly, Virginia, USA, and was issued a Form 483 with five observations in December. “We now wish to inform that GPI has received a communication from the U.S. FDA indicating the inspection classification as Voluntary Action Indicated,” the parent company said.
The U.S. FDA classifies inspections as no action indicated (NAI), or no objectionable conditions or practices were found during the inspection; VAI that means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action; and official action indicated (OAI) that means regulatory and/or administrative actions are recommended.
