Hyderabad, Mar 5 (TNT): Granules India Limited on Thursday said its US step-down subsidiary Granules Consumer Health, LLC has received an Establishment Inspection Report (EIR) with a No Action Indicated (NAI) status from the U.S. Food and Drug Administration following a recent inspection.
The FDA conducted the inspection at the company’s packaging facility in Manassas, Virginia from December 1 to 3, 2025. This was the facility’s second FDA inspection, after a March 2023 audit that also concluded with zero observations.
Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India, said the achievement reflects the company’s strong quality and regulatory standards.
“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 the strong culture of quality, safety and regulatory excellence demonstrated by our teams,” he added.
Granules Consumer Health functions as the front-end division for OTC products in the United States, leveraging Granules India’s manufacturing efficiencies, regulatory compliance and integrated supply chain.
The facility is responsible for packaging both OTC and prescription (Rx) products and also serves as a distribution hub for OTC products across the United States.
TNT KS
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