Granules packaging facility completes U.S. FDA inspection sans observations

Generic drugmaker Granules India’s packaging facility in the U.S. completed a GMP inspection by the U.S. Food and Drug Administration (FDA) with zero observations.

This was second U.S. FDA inspection of Granules Consumer Health facility’s and follows the March 2023 audit that resulted in a no action indicated (NAI) classification by the regulator, Granules said on Thursday (December 4, 2025).

Granules Consumer Health, a step-down subsidiary, serves as the front-end division for OTC products in the U.S. It plays a critical role in “our global operations as a packaging and distribution site. We process controlled substances and over-the-counter (OTC) products across three advanced packaging lines,” Granules India CMD Krishna Prasad Chigurupati said.