Granules India Limited announced that 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 of its packaging facility in Manassas, Virginia.
The US FDA inspection was conducted between December 1 and December 3, 2025, at the facility operated by Granules Consumer Health. The inspection concluded with no observations, leading to the issuance of an EIR with NAI status, which indicates that the regulator did not identify any objectionable conditions or practices during the audit.
This marks the second successful inspection for the Manassas packaging facility. The site had previously undergone an FDA audit in March 2023, which also ended with zero observations, highlighting the company’s continued compliance with regulatory standards.
Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India, said that Granules Consumer Health plays a crucial role in the company’s global operations as a packaging and distribution hub. The facility processes controlled substances and over-the-counter (OTC) products across three advanced packaging lines. According to him, receiving zero observations in the inspection reflects the strong culture of quality, safety and regulatory excellence maintained by the teams.
Granules Consumer Health functions as the front-end division for OTC products in the United States, leveraging Granules India’s manufacturing capabilities, regulatory compliance framework, and integrated supply chain. The facility is responsible for packaging both OTC and prescription (Rx) medicines while also acting as a distribution hub for OTC products across the US market.