Granules India announced that its US step-down subsidiary, Granules Consumer Health, LLC, a wholly-owned subsidiary of Granules Pharmaceuticals, Inc. has received an Establishment Inspection Report (EIR) with a No Action Indicated (NAI) Status from the US Food and Drug Administration (FDA).

The FDA inspection was conducted at the company's packaging facility in Manassas, Virginia, from December 1 to 3, 2025. This marks the facility's second FDA inspection, following the March 2023 audit, which also concluded with zero observations.