Granules India’s wholly-owned foreign subsidiary -- Granules Pharmaceuticals’, Inc. (GPI) USA facility inspection classified as ‘Voluntary Action Indicated’ (VAI) by USFDA. The VAI inspection classification indicates that the U.S. Food and Drug Administration (USFDA) will not take or recommend regulatory or enforcement action because the observations do not meet the threshold for action at this time.
Earlier, the USFDA had issued Form 483 with 5 observations post inspection on December 16, 2023, which has been now classified as VAI.
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
