Granules India reports completion of FDA inspection with zero observations

Granules India has announced that its U.S. step-down subsidiary, Granules Consumer Health, LLC, a wholly-owned subsidiary of Granules Pharmaceuticals, Inc., has completed a GMP inspection conducted by the U.S. Food and Drug Administration (FDA) with zero observations.

According to the company, this marks the facility’s second FDA inspection. The previous audit, conducted in March 2023, resulted in a No Action Indicated (NAI) classification.

“Granules Consumer Health 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. Achieving zero observations in this inspection reflects our unwavering focus on quality, safety, and regulatory excellence,” said Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India.

Granules Consumer Health functions as Granules’ front-end division for OTC products in the U.S., with operations supported by Granules India’s manufacturing efficiencies, regulatory compliance, and integrated supply chain.