Granules Life Sciences’ Hyderabad plant gets VAI inspection classification from U.S. FDA

Granules Life Sciences (GLS) manufacturing facility in Shamirpet, near Hyderabad, has been classified as voluntary action indicated (VAI) by the U.S. Food and Drug Administration (U.S. FDA) consequent to an inspection in December 2025.

The establishment inspection report (EIR) was issued following a current good manufacturing practice (cGMP) and pre-approval inspection (PAI) of the oral solid dosage manufacturing operations between December 15 and 19. The inspection is now closed and no regulatory action has been recommended, parent company Granules India said on Tuesday (March 31, 2026).

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The development strengthens Granules India’s finished dosage manufacturing capabilities by enabling multi-site manufacturing for the approved products, the company said.

Five observations issued

The U.S. FDA had issued five observations on completion of the inspection in December. The observations were related to procedural requirements. None of the observations are associated with data integrity or product safety, the company had then said. Granules Life Sciences is into manufacturing of pharmaceutical formulation intermediates (PFIs) and finished dosages.

“While receiving the [VAI] classification is a step in the right direction, we recognise quality is not a one-time milestone but an ongoing commitment. It will continue to remain a core pillar of utmost importance across all Granules sites,” CMD Krishna Prasad Chigurupati said.

VAI is one of the three classifications the U.S. FDA issues, in its EIR. VAI means objectionable conditions or practices were found, but it is not prepared to take or recommend any administrative or regulatory action. No action indicated (NAI) is another classification, which means no objectionable conditions or practices were found during the inspection. The third category of classification is official action indicated (OAI) that means regulatory and/or administrative actions are recommended.