The US Food and Drug Administration (USFDA) has completed its inspection of the Granules Life Sciences manufacturing facility in Shameerpet, a wholly owned subsidiary of Granules India, and issued a Voluntary Action Indicated (VAI) classification. The classification indicates that while certain observations may have been noted during the inspection, no regulatory action has been recommended by the USFDA, allowing the facility to continue operations without restrictions.
USFDA Inspection and EIR Issuance
The Establishment Inspection Report (EIR) was issued following a current Good Manufacturing Practice (cGMP) and Pre-Approval Inspection (PAI) conducted at the facility. The inspection took place between December 15 and December 19, 2025, and focused on the oral solid dosage manufacturing operations at the plant. With the issuance of the EIR, the inspection process has now been formally closed, confirming that no further regulatory action is required.
Reinforcing Commitment to Quality
Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India, emphasized the company’s ongoing commitment to maintaining high quality standards across its global manufacturing network. “While receiving the classification is a step in the right direction, we recognise that quality is not a one-time milestone but an ongoing commitment. It will continue to remain a core pillar of utmost importance across all Granules sites, guiding our actions, investments, and culture every day,” he said.
Strengthening Manufacturing Capabilities
The successful completion of the inspection also strengthens Granules India’s finished dosage manufacturing capabilities. According to the company, the development will enable multi-site manufacturing for approved products, providing greater operational flexibility and supporting the company’s ability to meet growing global demand for pharmaceutical formulations. As reported by thehindubusinessline.com, the USFDA’s VAI classification highlights Granules India’s continued focus on regulatory compliance, quality manufacturing, and expansion of its pharmaceutical production capabilities.
